Instrument and methods for surgically closing percutaneous punctures

ABSTRACT

A closure device for sealing a percutaneous puncture in a wall of a body passageway, the closure device including at least one of a toggle configured to engage an interior surface of the body passageway or a plug configured to engage an exterior surface of the body passageway and a guide wire configured to extend from an outside of the body to inside the body passageway, wherein at least one of the toggle and the plug is associated with the guide wire.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/605,720 filed Sep. 6, 2012, which claims the benefit of U.S.Provisional Patent Application No. 61/551,251, filed on Oct. 25, 2011,entitled “LARGE BORE VASCULAR SEALING DEVICE AND METHOD,”, and U.S.Provisional Patent Application No. 61/621,409, filed on Apr. 6, 2012,entitled “GUIDE WIRE THROUGH TOGGLE,”the entire contents of theseapplications are herein incorporated by reference into the applicationfor all purposes.

FIELD OF THE INVENTION

The present invention relates generally to closing percutaneouspunctures.

BACKGROUND

U.S. Pat. No. 5,282,827 (hereinafter, the '827 patent), entitledHemostatic Puncture Closure System and Method of Use, discloses systemsfor sealing a percutaneous incision or puncture in a blood vessel. Thesystems of the '827 patent comprise a closure device, an introducer, anda deployment instrument including a carrier for the closure device. Theclosure device has three basic components, namely, a sealing member, anintra-arterial anchor, and a positioning member.

The sealing member is in the form of an elongate, rod-like plug, e.g., acompressed hemostatic, resorbable collagen sponge or foam. This plugmember is arranged for sealing the puncture. The anchor is an elongate,stiff, low-profile member which is arranged to be seated inside theartery against the artery wall contiguous with the puncture. The anchoris molded of non-hemostatic resorbable polymer similar to conventionalresorbable sutures.

The positioning member comprises a filament, e.g., a resorbable suture.The filament connects the anchor and the collagen plug (sealing member)in a pulley-like arrangement, and includes a portion extending outsidethe patient's body. The outwardly located filament portion is arrangedto be pulled, i.e., tension applied thereto, after the anchor is locatedwithin the interior of the artery and in engagement with the inner wallof the artery contiguous with the incision or puncture. The pulling onthe filament causes its pulley arrangement to move the plug in thepuncture tract toward the anchor. A tamper forming a portion of thedeployment instrument is slid down the filament while the filament ismaintained in tension to gently tamp the plug in the puncture tract tocause the plug to deform so that its diameter increases. Tension ismaintained on the filament by use of an externally located spring duringthe tamping procedure.

The expansion of the plug within the tract is enhanced by the fact thatit is formed of a compressed collagen so that it expands in the presenceof blood within the puncture tract. The expansion of the plug within thepuncture tract serves to hold it in place. Moreover, the closure devicequickly becomes locked in place through the clotting of the hemostaticcollagen plug within the puncture tract. The spring serves to hold theplug in its deformed state until such time that the plug is locked inplace by the hemostatic clotting action. Once this has occurred, so thatthe plug is effectively locked within the puncture tract, the externallylocated spring can be removed. This typically occurs after approximately30 minutes. After the spring is removed, the filament is severed at thetop of the tamper. The tamper is then removed and the remaining portionof the filament is cut subcutaneously prior to the discharge of thepatient. The portion of the filament connecting the anchor to the plugremains in tension, thereby holding the closure device permanently inplace until it is eventually absorbed by the patient's body.

U.S. Pat. No. 5,662,681 (hereinafter, the '681 patent), entitledSelf-locking Closure for Sealing Percutaneous Punctures, also teachessystems for sealing a percutaneous incision or puncture in a bloodvessel.

SUMMARY

According to one aspect there is a closure device for sealing apercutaneous puncture in a wall of a body passageway, the closure devicecomprising at least one of an anchor configured to engage an interiorsurface of the body passageway or a plug configured to engage anexterior surface of the body passageway and a guide wire configured toextend from an outside of the body to inside the body passageway,wherein at least one of the anchor and the plug is associated with theguide wire.

According to another aspect, there is a deployment instrument fordeploying a closure device for sealing a percutaneous puncture in a wallof a body passageway, the deployment instrument comprising the closuredevice a carrier device, wherein the carrier device is configured tohold the closure device in a pre-deployment state and a guide wire, theguide wire passing through at least a portion of the closure device.

According to another aspect, there is a deployment instrument fordeploying a closure device for sealing a percutaneous puncture in a wallof an artery, the deployment instrument comprising the closure device,wherein the closure device includes a toggle and a plug connected to thetoggle and an actuatable assembly having a portion configured to extendinto the artery such that the toggle is located in the artery while, ina first state, effectively maintaining a relative position of the togglewith respect to an actuatable component of the deployment instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention are described herein with referenceto the attached drawing sheets in which:

FIG. 1 is a diagram showing the clinical setting of a large bore sheathand a guide wire;

FIG. 2A is a diagram depicting a closure device;

FIG. 2B is a cross-sectional view of the closure device of FIG. 2A;

FIG. 3A is diagram of an exemplary deployment instrument according to anexemplary embodiment;

FIGS. 3B-3F depicts additional details of the deployment instrument ofFIG. 3A;

FIG. 3G depicts an exemplary kit according to an exemplary embodiment;

FIGS. 4 and 4A are diagrams showing how an exemplary closure device isinserted into and removed from the artery;

FIG. 5 is a diagram showing how the sheath and the closure device arepositioned in the large arteriotomy;

FIG. 6 a diagram showing how the toggle is released in preparation fordeployment;

FIGS. 7-8B are diagrams showing how the device is deployed to seal thepuncture;

FIGS. 9A-9F depict exemplary toggle-guide wire associations;

FIGS. 10A-C depict exemplary toggle-filament associations;

FIGS. 11A-C depict exemplary tampers;

FIG. 12A-B depict exemplary features of a tamper;

FIG. 13 depicts an alternate embodiment of a deployment instrument;

FIG. 14 depicts use of the embodiment of FIG. 13;

FIGS. 15-18 depict features of an exemplary tensioner according to anembodiment;

FIG. 19 is a flowchart of an exemplary method;

FIGS. 20A-B depict an embodiment utilizing a plurality of plugs;

FIG. 21 depicts an embodiment utilizing a dual-lumen tamper;

FIG. 22-23 depict use of an occlusion balloon to hold a toggle againstan artery wall;

FIGS. 24A-D depict an alternate embodiment of a toggle;

FIGS. 25A-C depict an end view of use of a balloon to hold a toggleagainst an artery;

FIGS. 26A-B depict an alternate embodiment of a toggle;

FIG. 27A-D depict an exemplary embodiment of a marker; and

FIGS. 28-30 depict exemplary embodiments of guide wire-plug association.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Some exemplary embodiments are directed towards wound (puncture) closuredevices, systems and methods, and wound (puncture) closure devicedeployment instruments and methods and systems of utilization thereof,associated with closing a relatively large puncture (wound) of anartery, such as by way of example, a femoral artery. Such a largepuncture may exist as a result of a balloon aortic valvulopasty (BAV)and/or percutaneous aortic valve replacement (PAVR) procedure and/or arelated procedure, which utilize access sheaths from the 18 to 24F size.Hereinafter, these procedures (BAV, PAVR and related procedures) may bereferred to as the “referenced vascular treatment procedures.”

An exemplary embodiment of the wound closure system detailed below andsome variations thereof interface with an intravascular guide wire.Accordingly, some exemplary embodiments of use of thereof will first bedetailed, followed by a discussion of some specific features to thewound closure system of some exemplary embodiments.

In an exemplary embodiment, a needle cannula usable in a valvulopastyand/or percutaneous aortic valve replacement procedure is inserted intoan artery. Such a needle may correspond to, by way of example and not byway of limitation, a needle usable in the Seldinger method.

While the needle cannula is in place (extending into the artery), aguide wire is passed through the cannula of the needle a desireddistance into the artery (sufficient for the teachings detailed hereinand/or variations thereof to be practiced, and/or other procedures to bepracticed). In an exemplary embodiment, the guide wire is a so-calledthirty-five thousandths of an inch guide wire. In an exemplaryembodiment, the guide wire is an access guide wire. Once the guide wireis in place, the needle cannula is removed by pulling the needle awayfrom the artery over the guide wire. This leaves the guide wire inplace, with a portion thereof extending the desired distance (orthereabouts) into the artery. This further leaves an incision throughwhich the guide wire extends. As will be detailed below, in an exemplaryembodiment, the guide wire is part of a wound closure device deploymentinstrument, although in other exemplary embodiments, the guide wire is aseparate element.

An introducer sheath, such as a large bore sheath, is passed over theguidewire, through the incision and into the artery, as depicted in FIG.1, where element 10 is a large bore sheath, element 20 is a guide wire,element 1026 is a femoral artery (depicted in cross-sectional view),element 1024 is the puncture in the artery (wound in the artery),element 1025 is the tract leading to the puncture 1024 and element 1028is the skin. By tract it is meant the passageway in the tissue locatedbetween the artery 1026 and the skin 1028 of the being, and which isformed when the artery is punctured percutaneously.

It is noted that the scene depicted in FIG. 1 may be achieved throughother steps than those just depicted by way of example. Any method ormethods that result in the human tissue-medical device interface regimedepicted in FIG. 1 and/or variations thereof, which enable the teachingsherein and/or variations thereof and/or result in the utility of theteachings detailed herein and/or variations thereof, may be used in someembodiments. Indeed, the aforementioned actions may be part of or besubstituted by actions that are part of the referenced vasculartreatment procedures. In any event, after executing such actions, alarge bore sheath 10 remains in a vessel, such as the common femoralartery, as depicted by FIG. 1 and/or a variation thereof.

As can be understood by the diagram of FIG. 1 and attention to thesizing (unless otherwise noted, the drawings herein are drawn to scale),the sheath 10 is relatively large in relation to the inner diameter ofthe vessel (e.g., it has an inner diameter and/or an outer diameter ofabout 0.4, 0.5, 0.6, 0.7 and/or 0.8 or more times the size of the innerdiameter of the artery, as measured on a plane lying normal to thelongitudinal axes of these tubular structures). In this regard, thesheath 10, as it is a large bore sheath, requires a transverse slit(i.e., a slit extending axially) in the artery which will be relativelylarge (sufficient to receive the sheath 10 therethrough, after theelastic nature of the artery is taken into account).

In an exemplary embodiment, the guidewire 20 is utilized for advancementof a wound closure device deployment instrument through the sheath 10 ingeneral, and movement of a wound closure device in particular along theguide wire. It is noted that some exemplary details of the deploymentinstrument and closure device are provided below. However, in someembodiments, the deployment instrument and/or closure device maycorrespond to the deployment instrument and/or wound closure device ofany of the above referenced applications as modified to interface withthe large bore sheath 10 and/or closure device and/or deploymentinstrument detailed below, wherein the closure device may correspond tothe closure device of any of the above referenced applications asmodified to close such a large opening in the artery (e.g., an openinglarge enough to permit a sheath of 18F to fit through as depicted in theFIGs.).

Also shown in FIG. 1 is a PTA balloon 600 inserted proximally or from acontralateral puncture site. This balloon is utilized to block bloodflow proximal to the large bore puncture site (i.e., the site depictedin FIG. 1), and as an entry for contrast dye. Balloon 600 is depicted inan un-inflated or semi-inflated state coupled to guidewire 610. In use,inflation fluid is pumped to the balloon, to inflate the balloon 600. Itis noted that some embodiments may not include the balloon 600/may notutilize the balloon 600.

An exemplary embodiment of a closure device will now be brieflydescribed in the context of the environment of FIG. 1, with someadditional details of the closure device being provided further below.

At some point during the aforementioned procedure, the incision in theartery is utilized for whatever medical purposes associated with theutility of the incision. After such utilization, there is utilitarianvalue in closing the incision. An exemplary embodiment of a closuredevice for closing the incision will now be described in the context ofthe artery 1026.

FIG. 2A depicts an exemplary closure device 85 closing puncture 1024.The closure device 85 includes toggle 30, plug 50 (often referred to inthe art and herein as a sealing member or collagen pad, or simplycollagen), lock 60, and suture (also referred to in the art and hereinas filament) 80, in the fully deployed state with the suture 80 cutbelow the skin level 1028 (the occlusion balloon is depicted in theun-inflated/deflated condition. FIG. 2B depicts a cross-sectional viewof the artery 1026, which details the fit of the toggle 30 to theinternal diameter of the artery, and also depicts the profile of thetoggle 30 with respect to the longitudinal axis of the artery 1026.

FIGS. 2A and 2B depict by way of example the closure unit 85 (comprisingtoggle 30, collagen 50, lock 60, and suture 80) in the fully deployedstate with the suture 80 cut below the skin level, and the occlusionballoon deflated to re-establish blood flow in the vessel and depict thefit of the toggle 30 to the internal diameter of the vessel,highlighting the low profile of the toggle design, as seen along thelongitudinal axis of the vessel.

In an exemplary embodiment, the closure device 85 can correspond to anyof the above referenced applications as modified to close such a largeopening in the artery (e.g., an opening large enough to permit a sheathof 18F to fit through as depicted in the FIGs.) and/or to provide analternate access pathway if needed during the procedure in which themethod is executed.

For example, suture (filament) 80 can correspond to filament 34 of U.S.patent application Ser. No. 13/111,653 (hereinafter, the '653application) filed on May 19, 2011, entitled DEPLOYMENT INSTRUMENT FORCLOSURE DEVICE FOR PERCUTANEOUSLY SEALING PUNCTURES, the teachings ofthe '653 application relating to the construction and features of thefilament being incorporated by reference herein for use in an embodimentherein. Lock 60 can correspond to lock 36 of the aforementioned '653application (or any other lock detailed therein and variations thereof),the teachings of the '653 application relating to the construction andfeatures of the lock being incorporated by reference herein for use insome embodiments herein. Collagen 50 can correspond to plug 30 of theaforementioned '653 application, although it is noted that the size ofplug 30 may vary from that disclosed in the '653 application, theteachings of the '653 application relating to the construction andfeatures of the plug 30 being incorporated by reference herein for usein an embodiment herein.

While the toggle 30 is different in size and geometry from thatexplicitly disclosed in the '653 application with respect to that anchor32 detailed therein, in an exemplary embodiment, the toggle 30corresponds to the anchor 32 of the '653 application in a modified formin accordance with the teachings detailed herein and/or variationsthereof, the applicable teachings of the '653 application relating tothe construction and features of the anchor 32 being incorporated byreference herein for use in an embodiment herein.

In an embodiment, the suture 80 is a braided multifilament size 2-0 PLLAsuture. The suture 80 can be made from any synthetic absorbable plasticmaterial that degrades as needed.

The plug 50 comprises a strip of a compressible, resorbable, collagenfoam which includes one or more apertures through which portions of thesuture 80 extend. In an embodiment, the plug 50 is a collagen pad madeof a fibrous collagen mix of insoluble and soluble collagen that iscross linked for strength. In an embodiment, the collagen may beobtained from the connective tissue of animals. The collagen may bepurified from the subdermal layer of cowhide.

The lock 60 comprises a cylindrical piece of resorbable iron and/orstainless steel crimped in a manner to provide a limited amount ofresistance to movement along the suture 80.

An embodiment of the toggle 30 is constructed of a 50/50polylactic-cogycolic acid or other synthetic absorbable polymer thatdegrades in the presence of water into naturally occurring metabolites(e.g., water and CO2). In an embodiment, the toggle 30 is a monolithicstructure formed by a bio-absorbable polymer.

It is noted that the aforementioned closure device 85 is an exemplaryclosure device, and alternate embodiments of such may be used in someembodiments. By way of example only and not by way of limitation, theaforementioned crimped lock may not be present, and instead, thefilament is looped and/or suturing is utilized to hold the relativelocations of the elements of the closure device 85 (e.g., plug 30 andtoggle 30). By way of example and not by way of limitation, the closuredevice may correspond to, scaled for application with large boreapplication or unscaled, that detailed in U.S. Pat. No. 5,282,827(hereinafter, the '827 patent) and/or variations thereof, the contentsof which are incorporated herein by reference in their entirety withrespect to the closure device taught therein. Further by way of exampleand not by way of limitation, the closure device may correspond to,scaled for application with large bore application or unscaled, thatdetailed in U.S. Pat. No. 5,662,681 (hereinafter, the '681 patent)and/or variations thereof, the contents of which are incorporated hereinby reference in their entirety with respect to the closure device taughttherein. Any device, system and/or method of closing the puncture thatutilizes a component that fits into the artery to provide a reactionelement (e.g., toggle 30) against a force applied thereto associatedwith closing the puncture and/or any device, system and/or method ofclosing the puncture that utilizes a plug (e.g., collagen plug 50) maybe used in some embodiments. In some other embodiments, any device,system and/or method of closing the puncture may be utilized.

An exemplary puncture (wound) of which the teachings detailed hereinand/or variations thereof can be utilized to close or otherwise beassociated with is a puncture in an artery having a diameter (inner orouter) of about 10 mm, although such teachings can also be applicable tosuch having a diameter (inner or outer) of about 5, 6, 7, 8, 9, 10, 11,12 and/or about 13 mm or more, or any value in between these valuesand/or any ranges encompassing some or all of these values (includingranges being bounded by the in between values). In an exemplaryembodiment, the puncture extends over an arc, transverse to alongitudinal axis of the artery (about the circumference normal to thelongitudinal axis) of about 90 degrees, although in some embodiments,the arc extends 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70,75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145,150, 155, 160, 165, 170, 175 and/or about 180 degrees, or any value inbetween these values and/or any ranges encompassing some or all of thesevalues (including ranges being bounded by the in between values). By wayof example, the puncture may extend along an arc having a length of 8mm, although in some embodiments, the length is about 3, 4, 5, 6, 7, 8,9, 10, 11, 12, 13, 14 and/or about 15 mm or any value in between thesevalues and/or any ranges encompassing some or all of these values(including ranges being bounded by the in between values).

As noted above, some additional exemplary features of the componentsthat make up the closure device 85 are further detailed herein. Prior tothat, however, a brief discussion of an exemplary deployment instrumentis provided (with additional details pertaining to the deploymentinstrument being provided further below) for deploying a closure devicesuch as closure device 85 and/or other equivalents thereof and/orvariations thereof.

FIG. 3A depicts an exemplary deployment instrument 100 according to anexemplary embodiment, configured to deploy the closure device 85. Asdescribed herein, deployment instrument 100 includes a closure device 85and a guide wire 20. However, in other embodiments, the deploymentinstrument may not include one or both of these elements.

Briefly, deployment instrument 100 is configured to be inserted intosheath 10. Deployment instrument 100 includes a release tube 40 and ahandle 110. Release tube 40 is configured to move relative to handle 110and release tube support 42 along longitudinal axis 101 via actuation oflever 90 clockwise or counter-clockwise relative to the handle, asdepicted by arrow 102. That is, movement of lever 90 moves release tube40 (sometimes referred to herein as restraining tube 40) inward/proximalto release the toggle 30.

More particularly, FIG. 3B depicts a cross-sectional view of the distalend of the deployment instrument 100, depicting additional components ofthe deployment instrument 100. As may be seen, deployment instrument 100includes a delivery tube 120 that is located within release tube 40. Theplug 50 of closure device 85 is located in the delivery tube 120, withfilament 80 extending past plug 50 to toggle 30. It is noted that plug50 may partially extend outside of tube 120. In an exemplary embodiment,delivery tube 120 corresponds to a carrier assembly (which can includeonly the delivery tube or can include additional components).

As may be seen, toggle 30 is located such that it is at least partiallylocated in the release tube 40. In some embodiments, it may be fullylocated in the release tube 40 (i.e., no part of the toggle 30 extendspast the distal tip of the tube 40. Toggle 30 is held in place byfilament 80. As will be described in more detail below, guide wire 20extends through delivery tube 120 and release tube 40, as well asthrough toggle 30 and/or plug 50. In this regard, FIG. 3C depicts a topview of the distal end of deployment instrument 100, with FIG. 3Ddepicting a side view thereof for comparison purposes. As may be clearlyseen in FIG. 3C, the guide wire 20 extends through toggle 30 (throughthe longitudinal center of the toggle 30). In an exemplary embodiment,the association of the guide wire 20 with the toggle 30 as detailedherein and/or variations thereof can have utility in that such mayensure or otherwise effectively and/or substantially increase thestatistical probability (at least with respect to that in the absence ofthe guide wire association) that the toggle is at least generally if notsubstantially or about perfectly centered relative to the incision inthe artery.

In an exemplary embodiment, irrespective of the presence or absence ofthe guide wire 20, the plug 50 is held within delivery tube 120 in amanner that is similar to and/or a manner that is the same as thatassociated with the plug 30 tubular carrier 102 of the '653 application,the teachings thereof relating to such being incorporated by referenceherein for use in an embodiment herein.

FIG. 3E depicts an end view of the deployment instrument 100 looking atthe distal end thereof.

In operation, movement of lever 90 on the delivery handle 110 of thedeployment instrument 100 in the direction of arrow 102 moves therelease tube 40 in the proximal direction to about the location depictedin FIG. 3F (although the tube 40 may be moved to other locations inother embodiments, such as to a more distal location). As may be seen,the toggle 30 is now completely outside the release tube 40, and is thus“released.”

In an exemplary embodiment, the deployment instrument 100 is a fullyintegrated system that includes the deployment device 85 and the guidewire 20. In an exemplary embodiment, it is packaged (in, by way ofexample, a sterilized manner). In an exemplary embodiment, it ispackaged in a hermetically sealed package. The guide wire 20 may bewound in a winding with a relatively large radius to avoid kinking theguide wire. FIG. 3G depicts an exemplary closure device kit 1000,including deployment instrument 100, closure device 85 and guide wire 20sterilized and hermetically sealed in package 900. In an exemplaryembodiment, kit 1000 may further include an insertion sheath 10 inpackage 900 and/or in a separate package attached thereto.

It is noted that in an alternate embodiment, the guide wire 20 is notpart of the kit and/or the delivery instrument 100. Instead, it is aseparate component that is threaded through the toggle 30 and/or theplug 50 after access to the delivery instrument 100 (and thus theclosure device 85) is obtained. Accordingly, an exemplary embodimentincludes a method whereby a user, such as a physician or an operationroom nurse or other professional passes an end of a guide wire through ahole in the toggle 30 or otherwise associates the toggle 30 with theguide wire, followed by deployment of the closure device 85.

Use of the deployment instrument 100 will now be detailed with respectto an exemplary deployment method of deploying the closure device 85.

With the sheath 10 in place as seen in FIG. 1, the deployment instrument100 is inserted into a proximal end (not shown) of sheath 10, and movedthrough the sheath 10 until the distal end of the instrument 100 endextends out of the distal end of the sheath 10, approximately as shownin FIG. 4. In an exemplary embodiment, the guide wire 20 extends throughthe deployment instrument 100, and the deployment instrument 100 slidesalong the guide wire 20 (guide wire 20 and sheath 10 are generally heldstationary, relative to artery 1026, while deployment instrument 100 ismoved through the sheath 10). In an alternate embodiment, the guide wire20 moves with the deployment instrument 100, at least to a certainextent.

More particularly, FIG. 4 depicts the relative locations of toggle 30,the end of the delivery tube 120, and the release tube 40 of thedeployment instrument 100 with respect to the distal end of the sheath10. This positioning is achieved by driving the deployment instrument100 through sheath 10, over the guide wire 20 and/or with the guide wire20, until the release tube 40, along with the closure device 85 ingeneral and the toggle 30 in particular, as detailed herein and/orvariations thereof (where toggle 30 and plug 50 and some of filament 80is visible in FIG. 4), is positioned as shown. The positioning can bedetermined via the use of one or more radiopaque markers 44 and/or 45 onthe release tube 40. The user, utilizing fluoroscopic methods, candetermine the position of radiopaque marker 45, and thus the releasetube 40, relative to the end of the sheath 10. In an exemplaryembodiment, the user stops driving the deployment instrument 100 intothe sheath 10 upon the marker 45 emerging from the sheath 10 (imagedusing fluoroscopic methods). It is noted that other devices, systemsand/or methods may be utilized to determine or otherwise estimate theposition of the end of the release tube 40 relative to the insertionsheath 10. For example, a channel which permits blood to followthrough/along the instrument 100 to a location that is visible by theuser upon the instrument 100 being so positioned may be used in someembodiments. An exemplary embodiment utilizes some and/or all of theteachings associated with determining or otherwise positioningintroducer sheath 28 and/or device 28 of U.S. Pat. No. 5,282,827, thecontents of which associated with such teachings are incorporated hereinby reference for use in some embodiments. Any device, system and/ormethod that will enable the position of the instrument 100 to bedetermined or otherwise estimated may be used in some embodiments. In analternate embodiment, the sheath 10 is sized and dimensioned and/or thedelivery instrument 100 is sized and dimensioned such that movement ofthe deployment instrument 100 through the sheath 10 stops at a certainpoint (e.g., a wall of the deployment instrument 10 abuts the sheath 10)such that the distal end of the deployment instrument 10 extends adistance past the distal end of the sheath 10 a distance havingutilitarian value.

As may be seen in FIG. 4, the toggle 30, which in this exemplaryembodiment, is smoothly shaped, is partially covered by the release tube40 upon its emergence from the sheath 10. Because it is exposed, thesmoothness has utility in that it can permit relatively smooth entryinto the artery and can allow for rearward movement of the closuredevice within the artery without risk of the toggle 30 catching on anyplaque or other obstruction. Given the anatomical nature of the accesssite and puncture, the release tube 40 (and the delivery tube 100,sheath 10 and guidewire 20 will be slightly curved as may be seen inFIG. 5. This curvature provides a biasing force on the toggle 30 for therelease actions.

Upon positioning of the deployment instrument 100 at the desiredposition relative to the distal end of the sheath 10 (i.e., at theposition depicted in FIG. 4), the lever 90 is rotated relative to therest of the instrument 100 in a direction and by a sufficient amount toretract the release tube 40 a utilitarian distance relative to deliverytube 120, thereby entirely exposing the toggle 30. FIG. 5 depicts suchan exemplary retraction. As may be seen, guide wire 20 extends throughtoggle 30 after retraction of the release tube 40.

Next, sheath 10 is withdrawn from the approximate position depicted inFIG. 5. However, prior to this, balloon 600 optionally can be inflatedas shown in FIG. 5. Because the sheath 10 may exit the puncture 1024when the sheath 10 is withdrawn from the artery, the balloon is inflatedunder a low pressure to block blood flow from a proximal position atleast prior to fully withdrawing the distal end of the sheath 10 fromthe artery (where blood flow flows from left to right with respect tothe frame of reference of FIG. 5).

As just noted the insertion sheath 10 is withdrawn from its previousposition, either partially and/or fully out of the artery 1026. FIG. 6depicts withdrawal of the insertion sheath 10. While the sheath 10 iswithdrawn, the relative position of the deployment instrument 100relative to the artery can change, either by the same amount or by alesser or greater amount, although in other embodiments, its locationrelative to the artery may remain the same. Any movement or lack thereofof the instrument 100 relative to the artery may exist in someembodiments providing that it does not negate the utilitarian value ofthe embodiment. Some such movement may be seen by comparing FIG. 6 toFIG. 5. In this regard, FIG. 6 depicts the deployment instrument 100 ingeneral, and the closure device 85 carried thereby, in a positionrelative to the puncture 1024 having utilitarian value.

It is noted that in an exemplary embodiment, plug 50 can be withdrawnfrom tube 120 without contacting the sheath 10 and/or at least withoutcontacting the interior of the sheath 10. This may, in some embodiments,eliminate the possibility that the plug 30 might become stuck in thesheath 10—during the deployment procedure as it expands once leaving thetube 120.

In an exemplary embodiment, a contrast agent is injected distal to theballoon 600. Contrast agent can indicate any leakage at the puncturesite and can additionally provide for an outline of the toggle 30 usingfluoroscopic methods.

FIG. 4A shows the device including radiopaque marker 44 positioned nearthe puncture. Because the sheath 10 may exit the puncture during thisstep, balloon 60 is inflated under a low pressure to block blood flowfrom a proximal position. Contrast is injected distal to balloon 60,which indicates any leakage at the puncture site and additional providesfor an outline of toggle 30 on the fluoroscope. The sheath 10 and/or thetube 40, are retracted (moved in the direction that would withdraw themfrom the patient) until the distal radiopaque marker aligns with thepuncture, as will be seen fluoroscopically. Given the anatomical natureof the access site and puncture, release tube 40 and sheath 10 will becurved slightly, as may be seen in FIG. 5. This curvature provides abiasing force on the toggle 30 for the release step, discussed withrespect to FIG. 6.

Still referring to FIG. 6, FIG. 6 depicts how the toggle 30 will bereleased from the biased state with retraction of the release tube 40.The release orients the toggle 30 parallel to the vessel axis. Releaseis confirmed by the alignment of the distal radiopaque marker 44 withthe end of the sheath 10 and/or markings on the handle (not shown). Notethat vessel occlusion is maintained during this action, and an outlineof the toggle will be visible to the user on the fluoroscope (as will bedetailed below, the toggle 30 may include material that is readilyapparent through fluoroscopy. Note further that, in an exemplaryembodiment, the contact of the most distal portion of the toggle 30 withthe artery wall forces the toggle 30 to rotate clockwise upon sufficientmovement of the release tube 40, thus aligning the toggle 30 in a mannerthat will statistically improve the chances that the toggle 30 will besufficiently aligned so as to statistically reduce the likelihood (atleast in comparison to the absence of such alignment), if notsubstantially eliminate or completely eliminate the likelihood that itwill be pulled out of the artery during subsequent actions. It is notedthat in some embodiments, radiopaque marker(s) may be located on thesheath 10, such as, by way of example, at the distal end/tip of thesheath 10. Such may be used, in some exemplary embodiments, to determinethe position of the sheath 10. For example, a sheath marker may beutilized to determine the position/estimate the position of the distalend of the sheath relative to the puncture. Such may have utility indetermining whether or not to further retract the sheath 10 from theartery based on the location of the marker. Still further by example,such may be used to determine the location of certain components of thedeployment instrument 100 (e.g., the release tube 40 and/or thedeployment tube 120, such as, by way of example, based on radiopaquemarkers thereon, etc.), relative to the sheath 10.

Next, the delivery instrument 100 is moved proximally such that thedistal tip thereof is moved from the location depicted in FIG. 6 to atleast about the location depicted in the functional schematic of FIG. 7(with sheath 10 not shown for clarity). This results in plug 50 beingcompletely withdrawn from the artery and toggle 30 being drawn closer tothe puncture 1024 and/or substantially or completely against thepuncture 1024. Guide wire 20 may move along with delivery instrument 100partially and/or fully, or may remain stationary while the deliveryinstrument 100 is moved to the location of FIG. 7 and locationsthereabouts. Continued movement of the delivery instrument 100 away fromthe puncture, to a location such as that depicted by way of example inFIG. 8A, pulls toggle 30 closer to the puncture and/or completelyagainst the puncture, and also pulls plug 50 out of the delivery tube120 and, as a result of a pulley action/synching action/lassoing actionbetween the filament 80, the toggle 30 and the plug 50, the plug ispulled towards the toggle 30 and thus the puncture 1024 (in someembodiments such that it contacts the artery wall), with guide wire 20having the movements or lack of movements detailed above. Below, anexemplary device that has utilitarian value in moving the plug 50relative to the toggle 30 is described.

Next, the delivery instrument 100 is moved further away from thepuncture to expose some additional components therein, such as, forexample, a tamper, the lock if not already exposed, and additionalfilament 80 (by exposed, it is meant that the delivery tube 120 (orother component of the delivery instrument 100) is pulled past thesecomponents such that the components emerge from the distal end of thetube 120 (or other component that carries these components)). It isnoted that such exposure may be achieved by pulling the handle 110 ofthe delivery instrument 100, which results in pulling of the deliverytube 120 (and the release tube 40), and other components.

FIG. 8B depicts an exemplary result of such movement of deliveryinstrument 10, where tamper 70 has been exposed from the delivery tube100 (not shown in FIG. 8B, as it is exemplary moved out of the fieldrepresented by FIG. 8B). It is noted that the procedure for exposing thetamper 70 and the tamper 70 itself may correspond to the teachings ofsuch exposure and the tamper detailed in the '827 patent, the '681patent and/or the '653 application, the contents of which related tosuch exposure and the tamper being incorporated by reference herein foruse in some embodiments (although it is noted that below, an alternatetamper and an alternate method of exposure and an alternate device forachieving such exposure is detailed).

More particularly, FIG. 8A represents by way of example how theretracting the sheath 10 and deployment instrument 100 can position thetoggle 30 to cover the interior of the puncture. FIG. 8B represents howfurther retraction of the deployment instrument 100 will deploy thecontents of the delivery tube 100, namely the collagen 50, lock 60, andtamper tube 70, which will allow the user to compress the collagen 50 inplace and deploy the lock 60 (in embodiments that utilize such a lock).In an exemplary embodiment, these components correspond to thosedisclosed in the '827 patent, the '681 patent and/or the '653application, and variations thereof, as might be scaled for use toprocedures disclosed herein. Moreover, the steps of achieving theresults depicted in these FIGS. may include some and or all of themethod steps disclosed in any of the '827 patent, the '681 patent and/orthe '653. As noted above and is further detailed below, toggle 30position can be confirmed fluoroscopically.

After utilitarian placement of the plug 50 relative to the toggle 30and/or puncture 1024, the plug 50 is locked in place by tamping lock 60with tamper 70 in the distal direction (as represented by arrow 17) asdescribed by way of example in the '653 application. Again, an exemplarydevice that has utilitarian value in tamping lock 60 is described below.

It is noted that in an exemplary embodiment, some or all of the featuresassociated with the methods of delivering the closure device 85(including securing the closure device in place) can correspond to thosevariously taught in the '681 patent, the '827 patent and/or the '653application as implemented utilizing the teachings detailed herein ingeneral and/or the teachings applicable to the delivery instrument 100and sheath 10 in particular, the applicable teachings of those patentsand applications being incorporated by reference herein for use in someembodiments. By way of example, the teachings of the '653 applicationassociated with pulling the plug towards the toggle prior to locking theplug in place may be used in some embodiments.

As detailed above, an exemplary embodiment utilizes a toggle thatmaintains an association with a guide wire. Some exemplary associationswill now be described.

FIG. 9A depicts an exemplary embodiment of a toggle 30A, which can be insome embodiments a large bore toggle, usable in at least someembodiments herein and methods herein. As may be seen, toggle 30Aincludes two holes 31 through which filament 80 may extend, as describedin greater detail below. (Additional features of the structuralarrangement of the toggle are also described below.) Toggle 30A may beutilized in an embodiment where there is no association between thetoggle and the guide wire.

In an exemplary embodiment, toggle 30A and/or the other toggles detailedherein and/or variations thereof are configured to utilitarianly fit toa 10 mm diameter (interior) artery. The toggle 30A has a curved profile,as may be seen in FIG. 9A, which depicts both a top view and a side viewof the toggle 30A. In an exemplary embodiment, the top profile of thetoggle 30A has a generally circular profile having a radius of R1, whichcan be about 5 mm, in an unrestrained configuration, although in someembodiments, the profile may be a radius of about 4 mm, 5 mm, 6 mm, 7mm, 8 mm, 9 mm, 10 mm, 11 mm and/or about 12 mm, or any value in betweenthese values and/or any ranges encompassing some or all of these values(including ranges being bounded by the in between values). It is notedthat in an exemplary embodiment, the aforementioned radii encompass aprofile that is not exactly circular, but instead is elliptical (hencethe use of the term “about”, which, as used herein with respect to anyteaching herein, unless otherwise noted, does not exclude exact valuesand the use of about also includes embodiments not so qualified (i.e.,includes exact numbers, tolerance as would be understood in the art). Inan exemplary embodiment, the toggle has an unrestrained width W1 ofabout 6 mm, although in some embodiments, the width W1 may be about 2mm, 3, 4, 5, 6, 7, 8, 9 and/or about 10 mm, or any value in betweenthese values and/or any ranges encompassing some or all of these values(including ranges being bounded by the in between values).

In an exemplary embodiment, the radius R1 and/or the width W1 and/orother pertinent dimensions are such that when applied to a given artery,the wing tips 37A and 37B, as opposed to the longitudinal tips 38A and38B, which run parallel to the longitudinal axis of the artery) contactthe artery wall prior to the center 39 of the toggle 30A. In anexemplary embodiment, the toggle 30A is made of elastomeric materialand/or is of a material such that, when sized and dimensioned for use,allows the toggle 30A to flex (elastically and/or plastically) such thatthe radius R1 and/or width W1 decreases slightly (to about the interiordiameter of the artery—with or without expansion of the artery (in somecases, the artery is about a zero elasticity tissue, such as may be thecase for statistically very elderly patients for a population in theUnited States of America or Europe)) to conform to or about conform tothe interior diameter, upon tensioning of the filament as detailedherein and/or variations thereof. In this regard, the upper surface maybe characterized as being slightly less curved and/or slightly flatterthan the interior surface of the artery (as taken on a plane normal tothe longitudinal axis of the toggle and the artery, which in someembodiments, will be parallel or substantially parallel and/oreffectively parallel during application).

In an exemplary embodiment, the longitudinal distance of the toggle 30A(tip 38A to tip 38B) is about 16 mm, although in some embodiments, thisdistance may be about 6 mm, 7, 8, 9 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20, 21, 22, 23, 24, 25, 26 and/or about 27 mm, or any value inbetween these values and/or any ranges encompassing some or all of thesevalues (including ranges being bounded by the in between values).

FIG. 9B depicts an alternate toggle, toggle 30B, which includes a hole32, as may be seen, which accommodates the guide wire 20. Particularly,guide wire 20 extends through hole 32, and hole 32 permits guide wire 20to slide or otherwise move therethrough. As may be seen, Hole 32 islocated at about the lateral center of the toggle 30B (lateral centerbeing on the lateral axis 301B, as may be seen) as well as or in thealternative, centered along the axis of the suture holes 31, which maybe slightly offset from the lateral axis 301B.

In an exemplary embodiment, the location of hole 32 is different thanthat depicted in FIG. 9B. For example, FIG. 9C depicts hole 32 locatedin the longitudinal center of the toggle 30C (longitudinal center beingon the longitudinal axis 301C, as may be seen), and/or, the hole 32 islongitudinally in between the holes 31 in the toggle. Any placement ofhole 32 in the toggle that will enable the teachings detailed hereinand/or variations thereof to be practiced or otherwise to haveutilitarian value may be implemented in some embodiments. Also, in someembodiments, association of the toggle with the guide wire is achievednot by a hole through the toggle, but via a notch on the edge of thetoggle, as may be seen in FIG. 9D, where toggle 30D has a notch 33. Suchan embodiment can further include one or more holes through which theguide wire extends. An exemplary embodiment that achieves associationwith the guide wire and the toggle via a notch that has a C-Shapedcross-section (or other equivalent cross-section that achieves thefollowing functional result) such that the guide wire is “trapped” orotherwise retained therein. For example, if the C-shaped interior of thenotch is such that the distance between the ends of the C is less thanthe maximum diameter of the guide wire 20, the guide wire should beretained therein. Alternatively, the notch exists, but the guide wire isnot trapped or otherwise retained in the notch. Any device, system andor method of achieving and/or maintaining an association between theguide wire and the toggle may be practiced in some embodiments detailedherein and/or variations thereof.

In an alternate embodiment, a suture hole may be utilized as a hole toachieve association between the toggle and the guide wire/a hole for theguide wire may be utilized to pass a filament 80 therethrough. FIG. 9Edepicts such an exemplary toggle 30E. Such may be achieved by making asuture hole with a larger diameter than that which is would otherwise bethe case for association with a suture alone.

FIG. 9F depicts an alternate embodiment where two holes 32 are utilizedto respectively associate two guide wires 20 with the toggle 30F.Accordingly, such an exemplary embodiment may utilize two guide wires.In some embodiments, three or more guide wires and a correspondingnumber or different number of association devices (e.g., holes, notches,etc.) are utilized.

FIG. 10A depicts an exemplary filament 80 weave through holes 31 of anexemplary toggle 30F, with element 81 corresponding to, for example,loop 50A and winding 52 as detailed in the '653 application, thecontents of which related to the loop and winding thereof beingincorporated herein by reference in an exemplary embodiment. It is notedthat the exemplary embodiment of FIG. 10A includes a suture hole 31spacing width W2 that is wider than that depicted in the exemplarytoggle of FIG. 9A. In an exemplary embodiment, the holes 31 are about 4mm from one another (W2 equals about 4 mm), although in someembodiments, W2 is about 2 mm, 2.5, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm,5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm and/orabout 10 mm or any value in between these values and/or any rangesencompassing some or all of these values (including ranges being boundedby the in between values). It is noted that the spacing between theholes 31 of the toggle of FIG. 9A correspond to about 1.5 mm. In anexemplary embodiment, the hole spacing is sized so as to providesufficient structure that provides utilitarian value with respect toproviding sufficient material to react against the tension applied tothe filament (e.g., it will not break the toggle during tensioning).

It is noted that the weave depicted in FIG. 10A is applicable to thetoggles detailed above and/or below. In exemplary embodiment, element 81is a collar as detailed in the '653 application. Any device system andor method of achieving the utilitarian value of element 81 (e.g., itsuse as a collar), which can include permitting the loop 82 establishedby filament 80 to reduce in diameter (like a lasso or the like) can beused in some embodiments.

FIG. 10B depicts an alternate embodiment utilizing more than two toggleholes 31. As may be seen, four holes 31 are used, through which filament80 is threaded. Such an exemplary embodiment can have utility byimproving pulley action for compressing the plug 50 (not shown in FIGS.10A and 10B), as compared to that resulting from the configuration ofFIG. 10A and/or FIG. 9A.

FIG. 10C depicts an alternate embodiment including a washer (resorbableand/or nonresorbable washer) 500 interposed as seen in the loop 82formed with toggle 30A (or any other toggles described herein and/orvariations thereof). Such may provide for utilitarian management of thewound/puncture at the access site. In an exemplary embodiment, washer500, upon deployment of the closure device 85, becomes located betweenthe vessel wall and the plug 50 (which is interposed in the loop betweenthe toggle 30A and washer 500, but not shown in FIG. 10C), or,alternatively, proximally of the plug 50. In an exemplary embodiment,the distance between the holes of the washer 500 corresponds to thedistance between the holes of the toggle 30A, although in an alternateembodiment, the holes have a different spacing than that of the toggle.(It is noted that the aforementioned hole spacings for the toggle and/orthe washer are centerline to centerline dimensions.)

In an exemplary embodiment, the holes of the washer are about 4 mm fromone another (W2 equals about 4 mm), although in some embodiments, thedistance is about 1 mm, about 2 mm, 2.5, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mmand/or about 10 mm or any value in between these values and/or anyranges encompassing some or all of these values (including ranges beingbounded by the in between values). It is noted that the spacing betweenthe holes 31 of the toggle of FIG. 9A correspond to about 1.5 mm. In anexemplary embodiment, the hole spacing is sized so as to providesufficient structure that provides utilitarian value with respect toproviding sufficient material to react against the tension applied tothe filament (e.g., it will not break the toggle during tensioning).

It is noted that an exemplary embodiment includes a toggle having threeholes 81 or more holes. In an exemplary embodiment, the three holes areutilized with a threaded double suture.

As noted above, delivery instrument 100 includes a tamper 70 therein.While some embodiments include a tamper and are otherwise configuredaccording to the tamper of the '827 patent, the '681 patent and/or the'653 application, an exemplary embodiment includes a tamper 71 thatprovides association between the tamper and the guide wire 20, as willnow be described.

An exemplary embodiment of tamper 71 is depicted in FIG. 11, andincludes a double-lumen. Specifically, tamper 71 includes lumen 80′,through which filament 80 extends, and lumen 20′, through which guidewire 20 extends. Lumen 80′ is sized and dimensioned, relative to theguide wire 20 and the filament 80, to permit movement of the tamper 71relative to the filament 80, and lumen 20′, in some embodiments, issized and dimensioned to permit movement of the tamper relative to theguide wire 20, while in other embodiments, it does not permit movementrelative thereto.

FIG. 11B depicts an alternate embodiment of a tamper, tamper 72, whichachieves association with the guide wire via the use of guide wirecarriers 20″, through which guide wire 20 extends, the functionalfeatures of tamper 72 being the same as and/or similar to that of tamper71. FIG. 11C depicts another alternate embodiment of a tamper, tamper73, which includes guide wire slot 20′″, through which guide wire 20extends, and is retained therein (slidably or otherwise) via bridges 21attached to the body of the tamper, the functional features of tamper 73being the same as and/or similar to that of tamper 71. An exemplaryembodiment that achieves association with the guide wire and the tamperdoes not include the bridges 21, while including the slot. The slot mayhave a C-shaped cross-section (or other equivalent cross-section thatachieves the following functional result) such that the guide wire is“trapped” or otherwise retained therein even in the absence of thebridges 21. For example, if the C-shaped interior of the slot is suchthat the distance between the ends of the C is less than the maximumdiameter of the guide wire 20, the guide wire should be retainedtherein. Alternatively, the slot exists, but the guide wire is nottrapped or otherwise retained in the slot. Any device, system and ormethod of achieving and/or maintaining an association between the guidewire and the tamper may be practiced in some embodiments detailed hereinand/or variations thereof. It is noted that the embodiment of FIG. 11Acan have utility in that it provides a level of safeguard against a userinadvertently gripping the guide wire or the like during tamping, wherein an exemplary embodiment, the tamper slides relative to the guidewireduring tamping.

FIG. 12 functionally depicts the environment in which tamper 71 isutilized. More particularly, after the delivery instrument 100 iswithdrawn as detailed above to expose the tamper and the othercomponents, tamper 71 is exposed as depicted in FIG. 12A. In theexemplary embodiment depicted in FIG. 12, guide wire 20 and filament 80extend through respective lumens 20′ and 80′. (FIG. 12B depicts across-section of tamper 71 taken at line A-A- of FIG. 12B, where theguide wire 12 and the filament 80 have been removed for clarity.)

In an exemplary embodiment, the tamper 71 (or 72 or 73 or variationsthereof) enables tamping action over/along the guide wire 20 and suture80, running through separate lumens 20′ and 80′ in the double lumentamper, until the tamper 71 contacts the lock 60. Upon contact, the userpushes down (continues to push down) on the lock 60 to compress the plug50 in place/to lock the already compressed plug 50 in place (such as isdone by way of example and not by way of limitation, as detailed in the'827 patent, the '681 patent, the '653 application, at least withrespect to movement along the filament thereof), without affecting theplacement of the guide wire 20. The double lumen tamper 71 enablesutilitarian support of the guide wire 20, as compared to the absence ofthe lumen for the guide wire (or the absence of the alternate componentsto achieve association with the guide wire) during the deployment of thedevice and/or can statistically improve user experience when tamping ascompared to tamping without such an association feature.

FIG. 13 functionally depicts an alternate embodiment of a deliveryinstrument 200. It is noted that some and/or all of the additionalfeatures (e.g., the tensioner apparatus, described below) described withrespect to instrument 200 may be included in instrument 100. It isfurther noted that an exemplary embodiment of deployment instrument 200includes some or all of the features of instrument 100 detailed above.

Briefly, movement of the release tube 40 relative to the delivery tube120 is achieved by applying force to section 214 of the release tube 40in the proximal direction of the deployment instrument 200, as indicatedby arrow 201, while applying a reaction force to the delivery tube 120at section 212 in the direction of arrow 202. Application of sufficientforce thereto drives the release tube 40 towards the proximal end of theinstrument 200, and moves it relative to the deployment tube 120, untilsection 214 abuts section 212 or until the force is reduced/eliminated.In this regard, the exemplary embodiment of FIG. 13 is such that thereis a slight friction fit between the tubes 40 and 120, although in analternate exemplary embodiment, the fit is a slip fit. Alternatively orin addition to this, additional components, such as an O ring or thelike, may be interposed between the tubes to generate a modicum offriction. Any device system and/or method of moving the tubes relativeto one another may be practiced in some embodiments.

In an exemplary embodiment, aside from the different mechanisms utilizedto move the tubes relative to one another, the functionality of thedeployment instrument 200 corresponds to that of the deploymentinstrument 100, as well as its use.

An exemplary embodiment includes a device, system and/or method ofgauging or controlling the application of tension on filament 80 whiledeploying the closure device 85 described herein. Specifically, theapplication of high tension on filament 80 may result in the togglepulling out. Alternatively, insufficient tension will not compress theplug 50 onto the exterior vessel wall.

Prior to describing an exemplary embodiment of a tensioner assembly ofthe delivery instrument 100, some actions associated with deployment ofthe closure device 85 by the deployment instrument 100 will be brieflydescribed (some of which includes redescription and/or variations of thedescription above) in the context of the function of the tensionerassembly.

As detailed above, movement of the deployment instrument 100 in theproximal direction causes toggle 30 to engage the artery wall. As thetoggle 30 catches/engages, resistance will be felt by the user withincreased movement of the deployment instrument 100 in the proximaldirection.

With increased movement of the deployment instrument 100 away from thepuncture, the plug 50 is deployed into the puncture tract with thetoggle 30 engaging or catching the inner surface of the artery wallcontiguous with the puncture. The instrument 100 is then pulled furtheroutward. Inasmuch as the toggle 30 trapped against the interior of theartery wall, the continued retraction of the deployment instrument 100causes the filament 80 to pull the plug 50 out of the delivery tube 120of the deployment instrument 100 and into the puncture tract. As thedeployment instrument comes out of and/or is moved further away from thepuncture tract, continuous steady resistance will be felt as thetensioner assembly of the deployment instrument controls the force onthe filament 80 during the retraction procedure.

Continued retraction of the instrument 100 brings the tamper 70 out ofthe distal end of the deployment instrument 100 (thus exposing thetamper 70).

The retraction of the deployment instrument 100 carries the plug 50 intoengagement with the exterior of the artery wall immediately adjacent thepuncture. Continued retraction causes the filament 80 to deform the plug50, i.e., cause it to deform radially outward, in an exemplaryembodiment, as detailed by way of example in the '827 patent, the '681patent and/or the '653 application, the contents of which relating tosuch deployment/expansion/positioning of the plug incorporated byreference herein for use in embodiments associated with deployment ofthe closure device 85. In an embodiment, the plug 50 (which may be acollagen pad, as noted above) is forced to fold down after exiting thedelivery tube 120 (in some embodiments, it begins to fold downimmediately upon exiting the delivery tube 120). The existence of bloodwithin the puncture tract can further contribute to the deformation ofthe plug 50, because, in some embodiments, it is collagen foam thatexpands and softens in the presence of blood. The retraction procedurecontinues to pull the deployment instrument 100 up the filament 80 untilthe user stops pulling. At this point the plug 50 should be located inthe puncture tract contiguous with the opening in the artery, and thelock 60 (if utilized) located immediately proximally of the plug.

The plug 50 is now ready to be positioned in the tract. To achieve thatend, the user compacts the plug 50 by gently tensioning the filament by,for example, pulling on the handle 110 of the delivery instrument 100 inthe proximal direction with one hand. This moves loop element 81 downalong the filament as a result of tension on filament. Here, toggle 30acts in an analogous manner to a pulley as described in, for example,the '653 application, the contents of which associated with that pulleyaction being incorporated herein by reference for use in an exemplaryembodiment utilizing such pulley action. This has the effect oftightening the loop 82. As element 81 moves down filament section totighten loop 81, it compacts plug 50. This forces plug 50 to conform tothe artery contiguous with the puncture in the artery.

Next, the tamper 71 is manually slid down the filament 80 by the user'sother hand so that it enters the puncture tract and engages the proximalside of the lock 60, if present. A force is applied to tamper 71sufficient to overcome the resistance to movement of the lock 71relative to the filament, at least if the lock 60 corresponds to thelock of the '653 application. This causes the lock 60 to slide downfilament section until it abuts element 81. An exemplary embodiment ofthe lock 60 is configured, when used in conjunction with filament 80, toprovide a certain amount of resistance to movement along filament 80.This locks element 81 in place, as, for example, taught in the '653application, thus preventing loop 82 from expanding. This feature causesthe plug 50 to be secured in the compact position until hemostasisoccurs (which happens relatively very quickly, thereby locking theclosure device in place). That is, because the plug 50 is compressedbetween the toggle 30 and the lock 60, plug 50 is retained or locked inposition within the puncture tract and cannot move away from the toggle,even before the blood clots in the plug.

In an exemplary instrument the deployment instruments detailed hereinand/or variations thereof include a tensioner assembly. Such a tensionerassembly will be described in terms of deployment instrument 200, butare readily applicable to deployment instrument 100, as will now bedescribed.

FIG. 13 depicts a cross-sectional view of deployment instrument 200,including tensioner assembly 140 in the form of a tensioner cartridge160. Tensioner cartridge 160 configured to gauge/measure and/or tocontrol the forces (e.g., tension in filament 80) resulting fromdeployment of closure device 85. The tensioner cartridge 160 providesthe user with visual and/or tactile and/or auditory feedback duringdeployment. The construction of the tensioning cartridge includes aspring 150 located inside a retractable tube 162 that allows for thepassage of filament 80 therethrough. The cartridge 160 includes aretractable member 170. In an exemplary embodiment, the retractablemember 170 is fixedly attached to the filament 80, such that tension onthe filament 80 imparts a force onto the retractable member 170, andthus spring 150. In an alternate embodiment, the filament 80 is attachedto one or more of the coils of spring 150 (e.g., the most proximalcoil/last coil), such that tension on the filament 80 imparts a forceonto the spring 150. In an alternate embodiment, the retractable member170 may include a soft tensioning member 172 through which the filament80 extends. The tensioner assembly 140 one or more utilitarianfunctions. For example, it controls the force applied to the filament 80(and thus the tension) by holding the filament taut during pull back ofthe instrument 200 (or 100) while providing a system for allowing theuser to guard against the application of too much force. By utilizingthe tensioner assembly 140 as detailed below, a user may apply adequatefilament tension for compressing the plug 50 and/or during tamping thelock 60 or other component.

The tensioner assembly may also provide tactile and/or visual and/orauditory indication for the user to stop pulling back and/or to stopapplying additional (increasing) force to the deployment instrument inthe distal direction when the end of suture length has been reachedthrough change in color, shape, etc., visible on the instrument. In anexemplary embodiment, this can prevent or otherwise enable safeguardingagainst excessive force being applied to the toggle, preventing thetoggle from pulling out of the blood vessel.

During use, application of a force onto deployment instrument 100 thatresults in a first tension on the filament is sufficient to withdraw thecartridge 160 out of the delivery tube 120, exposing the cartridge 160such that the user may handle the cartridge 160 with his or her hand. Inparticular, cartridge 160 is carried within delivery tube 120 such thatthere is a slight friction fit between the two components. This may beachieved, by way of example, via, elastomeric O-ring 174, as may beseen. Application of the first tension (by applying a sufficientwithdrawal force on the instrument 200 in the proximal direction) issufficient to overcome the friction forces and pull the cartridge 160out of the tube 120. Alternatively or in addition to this, a snap fit isutilized to retain the cartridge, and a sufficient force applied to theinstrument resulting in sufficient tension on the filament is sufficientto release the snap fit. In yet another alternative embodiment, apositive retention mechanism, such as an actuating cylinder or box beam,etc., that extends into the tube 120, and thus blocks the cartridge 160until it is moved out of the tube 120, or at least from in front of thecartridge 160, may be utilized to retain and then release the cartridge.Any device, system and/or method that can provide the modicum offriction between the cartridge 160 and the delivery tube 120 and/or thatprovides the modicum of securement so as to releasably retain thecartridge 160 in the delivery tube 120 until it should be exposed can beutilized in some embodiments. In this regard, it is noted that the firsttension may vary between embodiments. By way of example, the tensionassociated with overcoming the friction fit utilizing, for example, theO-ring, may be different from that associated with overcoming thesnap-fit. Moreover, the tension may be variable or generally constant.For example, the tension during withdrawal of the cartridge 160 from thedelivery tube 120 will be generally constant during the withdrawalprocess with respect to the friction fit utilizing the O-ring, whereasthe tension may vary during withdrawal with respect to the snap-fit orthe like. Embodiments where the tension is relatively constant, or atleast moderately increases within a range that does not result in damageto the artery wall and/or dislodgement of the toggle, can have utilityin that this results in a tension that generally maintains the toggle inplace against the puncture on the interior of the artery.

With respect to the embodiment of FIG. 13, where the O-ring results in afriction fit between the tube 120 and the cartridge 160, application ofthe first tension results in the ejectment/exposure of the cartridge160. This is schematically represented by way of example in FIG. 14.Upon sufficient exposure of the cartridge 160, the user grips thecartridge 160 with a free hand and gradually or abruptly begins to applyforce to the cartridge in the proximal direction at a level that is inequilibrium, in an exemplary embodiment, to that applied to theinstrument 200, until the cartridge 160 is completely free of thedelivery tube 120, at which point the tension in the filament 80 is aresult of force applied to the cartridge 160 in the proximal direction.

An exemplary embodiment of the present invention includes a deploymentinstrument 100 including an exemplary tensioner assembly 1110 as may beseen conceptually in FIG. 15. In an exemplary embodiment, the tensionerassembly 1110 conceptually corresponds to the cartridge 160 detailedabove, although as will be detailed below, in an exemplary embodiment ofthe cartridge 160, there are different features between the two.

A portion of the procedure involving deployment of the closure device 80in a recipient using the exemplary tensioner assembly 1110 of FIG. 15will now be described. As may be seen in FIGS. 15 and 16, the tensionerassembly 1110 includes a frame 1120 in which a hub assembly 1140 isslidably retained. Frame 1120 includes protrusions 1121 that interactwith O-ring 174. In this regard, frame 1120 corresponds to element 161of FIG. 13. The frame 1120 serves as a handle that the user may graspduring application of the closure device 85 to the recipient. In someembodiments, the handle is provided with knurling or tread grips or thelike to facilitate grasping by the user. The hub assembly 1140 includesa hub 1180 and a tensioner insert 1200 (and silicone tension block 1210,which provides friction to the filament as it uncoils). The hub assemblyis spring loaded by spring 1220 (which corresponds to spring 150 of thedevice of FIG. 13) in the proximal direction of the deploymentinstrument 200. That is, with respect to FIG. 15, the spring 1220 forcesthe hub assembly 1140 upward, relative to the frame 1120. Another way ofdescribing this is that the spring 1220 forces the frame 1120 downward,relative to the hub assembly 1140.

It is noted that alternate embodiments include structure that isdifferent from that detailed herein. Indeed, a visual comparison betweenthe embodiment of FIG. 13 and that of FIG. 15 reveals that there aredifferences. It is thus again noted that the structure detailed hereinis exemplary and conceptual, and can and/or will vary in implementation.In this regard, while the embodiment of FIG. 15 depicts a hub 1140 thatextends into the interior of spring 1220, the embodiment of FIG. 13. Hub1140 corresponds to retractable member 170 of FIG. 13. However,retractable member 170 does not so extend into the spring 150, as may beseen.

In an exemplary embodiment, the spring 1220 permits the tension onfilament 80 to be controlled/ensures that sufficient tensioning and nottoo much tensioning is applied to the filament during deployment of theclosure device 85, as will now be detailed.

Referring to FIG. 15, the tensioner assembly 1110 includes a filamentrecess between the tensioner insert 1200 and a filament cap 1240 inwhich filament 85 is wound in a coil section 80E, from which thefilament 80 travels to the closure device 85. The end of the filament80E is threaded through a hole 1240A in the filament cap 1240 and istrapped between the filament cap 1240 and a filament lock 1260 to holdthe end of the filament 80 in place. Filament lock 1260 may be held tofilament cap 1240 via a screw fit or a snap fit or through the use of anadhesive or a weld, etc. That said, in an alternate embodiment, thefilament 80 extends completely from one side of the hub 1140 (or theretractable member 170) to the other side thereof, and furtherproximally out of the frame 1120 (or element 161).

As may be seen in FIG. 15, a friction block 1210 is located in a cut-outsection of the tensioner insert 1200. In an exemplary embodiment, thefriction block 1210 is a silicon block that is dimensioned such thatwhen inserted in the hub 1180 along with tensioner insert 1200, acompressive force on filament 80 is applied by the friction block 1210and the hub 1140. In some exemplary embodiments, as will be described ingreater detail below, as the filament 80 (filament from section 80E) isdrawn from the spool of the tensioner assembly 1110, the user feels arelatively constant resistance and/or a relatively consistent resistanceas compared to other deployment instruments 100 (i.e., the resistancefelt with one deployment instrument 100 used during a given procedurewill be about the same as that felt during a prior procedure withanother deployment instrument 100). That is, the friction block 1210 incombination with the tensioner insert 1200 and hub 1140 function tocontrol the force required to at least initially withdraw the filament80 from the spool.

In an exemplary embodiment, friction block 1210 corresponds to softtensioning member 172 detailed above with respect to FIG. 13. As hasbeen noted above, the specific structure of various embodiments canvary, while utilizing the principles detailed herein.

As noted above, a force applied to deployment instrument 200 sufficientto result in a first tension in the filament can result in the cartridge160 (or tensioner assembly 1110) being exposed (withdrawn/released frominside delivery tube 120). As noted above, inasmuch as the toggle 30 istrapped (anchored) against the interior of the artery wall, thecontinued retraction of the deployment instrument 200 causes thefilament 80 to pull the plug 50 out of the deployment tube 120 of thedeployment instrument 200. Also, once the toggle 30 catches on the wallof the artery, the filament 80 (filament from section 80E or otherlocation where the filament is stored) will be drawn from the spool ofthe tensioner assembly 1110. Some resistance will be felt, at least inembodiments utilizing the friction block 1210 (or its correspondingstructure 172) described above (as opposed to other embodiments where nodrag force is applied to the filament as a result of compression of thefilament by the friction block, such as in the case where no frictionblock 1210/structure 172 is used and a bore or other space of thetension insert 1200 through which the filament 80 passes is oversizedrelative to the filament 80). This resistance may require the user toapply about ¾ths of a pound of force to the deployment instrument 200 topull the filament 80 out of/through hub 1180/structure 170. The usercontinues to pull the deployment instrument 200 away from the recipientwith a force sufficient to overcome the friction resulting from thecompressive force applied to the filament 80 by the friction block 1210.At a given distance of the deployment instrument 200 from therecipient/from the puncture, the filament 80 will be completely unwoundfrom the spool (or otherwise withdrawn through structure 172 until stop176 strikes structure 172 in the case of cartridge 160). FIG. 16 depictsthe tensioner assembly 1110 in the state where the filament 80 is about½ way unwound from the spool and FIG. 17 depicts the tensioner assembly1110 in the state where all of the filament 80 has been unwound from thespool. The tension on filament 80 is high enough to unwind the filamentfrom the spool, and potentially compresses spring 1220 by acorresponding amount.

At this point, with increasing force applied to the deploymentinstrument 200, the tension in filament 80 reaches a high enough value(the first amount detailed above) to overcome the friction forcesbetween the O-ring and delivery tube 120, and thus the cartridge 160 (ortensioner assembly 1110) becomes exposed exposed (withdrawn/releasedfrom inside delivery tube 120).

At this point, the user grips the cartridge 160 or frame 1120, andcontinues to withdraw the cartridge 160 or frame 1120 away from therecipient with a steady or increasing force. When the tensioner assembly140 1110 is located a first linear distance from the vessel wall,because the end of the filament 80 (or other part of the filament 80) istrapped between filament cap 1240 and the filament lock 1260 (or element176 abuts structure 172), continued pulling of the tensioner assemblyaway from the recipient (past the first distance), when the user holdsthe frame 1120 (or element 162) causes the filament 80 to become moretensioned because the “unwinding” of the filament 80 from the spool hasstopped (there is no more filament from section 80E to be unwound) andthe end of the filament 80 is held in place as it is attached to thetensioner assembly. Accordingly, this increase in tension as the usermoves the deployment tensioner assembly from the first distance from thevessel wall causes frame 1120 (or element 162) to move relative to hubassembly 1140 and thus causes spring 1220 (or spring 150) to compress orfurther compress. The force compressing the spring is substantiallyequal to the tension in the filament 80. As the tension of the filament80 progressively increases as the user continues to pull the tensionerassembly 200 away from the recipient (via pulling on the frame 1120 orelement 162), the spring 1220 continues to be compressed, thus resultingin a gradual increase in the tension of the filament 80 as the tensionerassembly is continued to be pulled away from the recipient. This ascompared to the relatively sudden increase in tension that would existif the hub assembly 1140 were instead rigidly fixed to the tensionerassembly 1110 and/or the spring 1220 were not present (or if structure170 were instead rigidly fixed to the tensioner assembly 140 and/or thespring 150 were not present. In this regard, the spring 1220/spring 150provides a dampening or cushioning effect with respect to the forceapplied to the inner wall of the blood vessel or other body passagewaywhich reacts against the toggle 30 at the time that the filament 80 isfully unwound from the spool. Thus, there should be no sudden increasein the force/pressure on the wall at the location of the toggle 30.Instead, there should be a gradual increase in the force/pressure on thewall at the location of the toggle 30. In an exemplary embodiment, thehub assembly 1140 may travel about eight (8) millimeters upon theapplication of about two (2) pounds of tension force in the filament 80before bottoming out (i.e., the hub assembly 1140 cannot move furtherdownward/frame 1120 cannot move further to the upward with respect toFIG. 15). Thus, an embodiment provides a mechanically induced increasingtension force applied to the filament that increases with increasingdistance of the tensioner assembly away from the puncture at a rate ofless than about 1.5 pounds per 4 mm of increased distance of thedeployment instrument away from the puncture. Accordingly, in anexemplary embodiment, pulling the tensioner assembly away from thepuncture while the filament is connected thereto results in an initialcontact of the anchor to the wall of the body passageway followed by agradual increase in pressure applied to the wall by the anchor whiletension in the filament is less than about two (2) pounds. Thus, via amechanical device of the deployment instrument 200, a sudden increase inpressure applied to the wall of a body passageway by the toggle 30 isavoided.

FIG. 18 depicts spring 1120 fully compressed upon the application of two(2) pounds of tension force in the filament 80 by the user whilefilament 80 is connected to toggle 30 (which, as noted above, is lodgedin the artery). By bottoming out the hub assembly 1140, and not pullingon the tensioner assembly too much more after that, the user can ensurethat he or she has applied about two (2) pounds of tension force on thefilament 80, and not too much more. This ensures that sufficient tensionhas been applied to the filament to properly deploy the closure device85, and not too much more. Also, the spring 1220/spring 150 at leastpartially reduces what otherwise might be a spike in the force appliedto the wall of the artery upon the filament 80 becoming completelyunwound from the spool and becoming unslackened due to movement of thetensioner assembly away from the recipient.

In an exemplary embodiment, the user feels/senses the gradual increasein tension as the spring 1220/spring 150 is compressed (as compared tothe relatively static tension resulting from friction block 1210/element174), and thus is provided an indication that the tensioner assemblywill soon reach the mechanical limits of its withdrawal away from therecipient, after which any further withdrawal will be due to the plasticand/or elastic nature of the filament and the recipient. In someembodiments, the spring 1220 is a linearly compressible spring, and thusthe gradual increase in tension as the spring 1220 is compressed islinear. Non-linear compressible springs may also be used, in which casethe gradual progressive increase in tension is not linear. In anexemplary scenario of use, the user continues pulling the tensionerassembly away from the recipient until the spring 1220/spring 150bottoms out, and then halts further movement of the tensioner assemblyaway from the recipient. Alternatively, the user can continue to pullthe tensioner assembly away from the recipient, thereby furtherincreasing the tension in the filament 80. Even with respect to thislatter scenario, the indication afforded to the user by the spring1220/spring 150 provides the user with an opportunity to adjust thedeployment procedure to avoid injury to the recipient and/or damage tothe closure device, etc.

It is noted that as the tensioner assembly 100 is pulled away from therecipient, and by the time that the spring 1220 has bottomed out, thepulley arrangement of the filament 80 connecting toggle 30 and the plug50 causes the plug 50 to be moved into engagement with the exterior ofthe artery wall contiguous with the puncture. The tension in thefilament 80 resulting from pulling the tensioner assembly away from therecipient causes the filament 80 to somewhat deform the plug, i.e.,cause it to deform radially outward and, in some embodiments, twist.Because the spring 1220/spring 150 permits the tension on filament 80 tobe controlled/ensures that sufficient tensioning and not too muchtensioning is applied to the filament during deployment of the closuredevice 20, the user is provided with some reassurance that the properamount of tensioning has been applied to the filament 80 to deform theplug and properly deploy the closure device 20.

It is noted that in an exemplary embodiment, plug 50 can be withdrawnfrom tube 120 without contacting the sheath 10 and/or at least withoutcontacting the interior of the sheath 10. This may, in some embodiments,eliminate the possibility that the plug 30 might become stuck in thesheath 10—during the deployment procedure as it expands once leaving thetube 120.

It is noted that an exemplary embodiment includes an indicator thatprovides an indication to the user that the hub assembly 1140 hasbottomed out within the frame 1120 (or corresponding structure). In anexemplary embodiment, the indicator corresponds to, at leastconceptually and/or functionally, to the indicator taught in the '653application, the contents of which pertaining to the indicator beingincorporated herein by reference in their entirety for use in anembodiment.

Accordingly, in an exemplary embodiment, referring to the flowchart ofFIG. 19, there is a method of sealing a percutaneous puncture in a wallof a body passageway, comprising, at step 1, providing a deploymentinstrument 100 including a tensioner assembly 1110/140 and carrying aclosure device 80, the closure device 80 including a toggle, a plug 50and a contiguous elongate filament 80 configured to draw the plug 50towards the toggle 30 upon the application of tension to the filament 80in a direction away from the toggle 30. At step 2, the distal end of thedeployment instrument 100 is positioned through the puncture into thebody passageway such that the toggle 30 is located in the bodypassageway. At step 3 the deployment instrument 100 is pulled away fromthe puncture while the filament 80 is connected to the deploymentinstrument. This results in the application of a mechanically inducedincreasing tension force to the filament 80 that increases withincreasing distance of the deployment instrument 100 away from thepuncture, thereby drawing the toggle 30 and the plug 50 towards eachother and into engagement with the wall of the body passageway atrespectively opposite sides of the wall. In an exemplary embodiment, themechanically induced increasing tension force is a result of spring, asdetailed above.

FIG. 20A depicts an embodiment that utilizes two plugs 50 and 50′, eachlocated on a portion of loop 82, with a single toggle 30. An exemplaryembodiment of such a configuration provides utility in that two plugsmay better seal a relatively large puncture. In this regard, somepunctures will extend a relatively great distance about the artery wallin a direction normal to the longitudinal axis thereof. For example, thepuncture may extend over an arc that extends about 20, 25, 30, 35, 40,45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160 170and/or about 180 degrees or more and/or angles in between these in onedegree increments. A single plug may bunch at the apex of the puncture,thus leaving portions of the large puncture exposed on either side ofthe plug. The use of two plugs covers more area, and thus can cover moreof the puncture. By way of example, a single plug may cover a punctureextending over an arc of 10 or 20 degrees, whereas two plugs may cover apuncture extending over an arc of about 25, or 35 or 40 or more degrees.Along these lines, the use of two holes 31 for the filament spreadrelatively far apart can space the plugs over the full area of thepuncture.

It is noted that the washer 500 detailed above can be used to spread outthe filament 80 so as to avoid or otherwise reduce the tendency of theplug to bunch at the apex of the puncture in a manner the same as orsimilar to the manner by which the more widely spaced holes 31 preventsor otherwise reduces the bunching tendency.

FIG. 20B depicts a cross-sectional view of a closure device according tothe embodiment of FIG. 20A after delivery.

As can be seen in FIG. 20A, the exemplary embodiment utilizing two plugs50 and 50′ can include two tampers 70 and 70′ to tamp locks 60 and 60′.Use of these additional components may correspond to the teachingsdetailed above, albeit sequentially (tamping lock 60 first with tamper70, and then tamping lock 60′ with tamper 70′).

Still referring to FIG. 20A, an exemplary embodiment includes analternate embodiment of a tensioner apparatus. Specifically, FIG. 20Adepicts a tensioning apparatus 400. In an exemplary embodiment,tensioning apparatus 400 corresponds to a spring that is biased suchthat the ends 401 and 402 of the spring are separated as shown in FIG.20A. Specifically, ends 401 and 402 can be wrapped about filament 80 asconceptually shown, or otherwise may include devices at the ends thatpermits the filament 80 to slide relative therethrough while holding thefilament 80. Upon tensioning the filament 80 as detailed herein, the twoportions of filament 80 between element 81 and the toggle 30 will tendto move towards each other. The tensioning apparatus 400 will resistthis movement owing to the spring bias just mentioned. The more tensionapplied to the filament 80, the greater the tendency for these portionsof filament 80 to move towards each other, thus compressing thespring/moving the ends 401 and 402 closer together. Accordingly, a usercan view the degree of closure of the spring/movement of ends 401 and402 closer to one another, and thereby determine or otherwiseestimate/gauge how much tension is being applied. In an exemplaryembodiment, a gauge may be included with tensioning apparatus 400 thatpermits the user to read the tension on the filament 80 owing to thelocation of the ends 401 and 402 (or the arms that support the ends)relative to the gauge. In yet an alternate embodiment, a spacer elementmay be present between the ends (or arms) that functionally permits thespring to bottom out in a manner akin to that detailed above withrespect to spring 1120/150, and thus having thefunctionality/utilitarian value of that configuration.

FIG. 21 depicts a variation of the embodiment of FIG. 20A, where insteadof two separate tampers, a single tamper 75 is present that includes twolumens through which the two sides of the filament that forms loop 82extends the same embodiment with a double lumen tamper used to includethe double sutures.

In another embodiment, the occlusion balloon 600 is moved distally fromthe occlusive position to the puncture site, whereby the occlusiveballoon 600 is utilized to assist with positioning the toggle 30 and/orthe plug 50 and sealing the puncture. Such is depicted by way of exampleand not by way of limitation in FIG. 22. Exemplary actions associatedwith such a procedure can include first position toggle intra-arteriallyas detailed herein and/or variations thereof in general, and, inparticular, with respect to FIG. 6. Once the toggle 30 is positionedproximate the puncture, the occlusion balloon is deflated. Next, theocclusion balloon 600 is moved from its occlusion position to a locationcorresponding to a longitudinally proximate position of the puncture.After this, the occlusion balloon 600 is re-inflated to occludingpressure and/or another pressure that will enable the teachings detailedherein and/or variations thereof to be practiced. This can push thetoggle 30 against the interior of the artery as shown in FIG. 22. Theuser can then double check the final position of the toggle 30 (usingfluoroscopy or the like) and/or make adjustments to the tension orpositioning of the plug 50 before deflating the balloon 600. (Beforedeflating the balloon, the closure device 20 may be secured in placeaccording to the teachings detailed herein and/or variations thereof, orsuch may be done after deflating the balloon.) FIG. 22 depicts an actionof this method, where it can be seen how the balloon 600 covers thetoggle 30 and puncture site. This the action associated with FIG. 22 canallow for full compaction of the plug 50 without any risk of orotherwise significantly statistically reducing the chances ofreinsertion of the plug within the artery as compared to that whichwould exist without use of the balloon 600.

An exemplary embodiment includes the use of a double balloon catheter,where the proximal balloon serves to occlude flow, while the second, andmoveable (slideable) balloon is utilized to assist with toggle andcollagen placement as above. FIG. 23 depicts an action associated with amethod of such an embodiment, where balloon 600′ is the occludingballoon and balloon 600 is the balloon that is used to position thetoggle 30.

FIGS. 24A, 24B and 24C depict an alternate embodiment of a toggle.Specifically, these FIGS. depict a toggle 135 having hinged wings orflaps 136 and 137 via hinge features 136A and 137A. Hinge features maybe barrel hinges or may be areas of relative weakness that enables thewings to hingedly move (or flap). Toggle 135 has a width W1 that islarger than the maximum internal diameter of the sheath 10 on a planenormal to the longitudinal axis thereof. In this regard, wings 136 and137 of the toggle 135 (e.g., portions outboard of the dashed lines seenin FIGS. 24A-24C), are located outboard of the inboard portion of thetoggle represented by main body 138. In an exemplary embodiment, theoutboard portions are flexibly connected or otherwise hingedly connectedto the rest of the toggle 135.

In an exemplary embodiment, the toggle 135 is configured to elasticallydeform at the areas of the hinges and/or thereabouts. By way of example,width W1 of FIG. 24A is a first value, corresponding to any of thevalues detailed above with respect to the tip to tip distance and/orvariations thereof, and this value corresponds to the value when thetoggle 135 is in the relaxed state. Upon the application of a force tothe wings, the value of W1 increases, by about 4 mm (about 2 mm for eachwing), although in alternate embodiments, the value W1 increases byabout 0.5 mm, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25,3.5, 3.75, 4, 4.25, 2.4, 4.75, 5, 5.25, 5.5, 5.75, 6, 6.25, 6.5, 6.75and/or any value in between these values and/or any ranges encompassingsome or all of these values (including ranges being bounded by the inbetween values).

This increase in value of W1, or at least a portion thereof, elasticallydeforms the toggle 135, such that it retains the new value of W1 orsomething close to that or something in between, depending on theelastic properties that come into play associated with the plasticproperties.

FIG. 24D depicts a cross-sectional view of toggle 135 through sectionA-A of FIG. 24C. As can be seen, hinge features 136A and 137A arenotched sections in the top surface of the toggle 135. In an alternateembodiment, the notches are located in the bottom surface. In analternative embodiment, the notches are located both above and below. Inan exemplary embodiment, hinge feature 136A is a notch located on thetop and hinge feature 137A is a notch located on the bottom, orvisa-versa. (The holes 31 are not depicted in the cross-sectional viewof FIG. 24D.)

Any device, system and/or method that enables the folding functionsdetailed herein and/or variations thereof with respect to the wings maybe utilized in some embodiments.

In an exemplary embodiment, the toggle 135 is such that the resistanceto flexture of the toggle along lines 136A and/or 137A is substantiallyand/or effectively less than resistance to flexture of the toggle atlocations generally proximately inboard and outboard thereof. In anexemplary embodiment, the toggle 135 is such that the elastic modulus ofthe toggle along lines 136A and/or 137A is substantially and/oreffectively less than that of the toggle at locations generallyproximately inboard and outboard thereof.

As noted above, the wings may expand upon the application of sufficientforce thereto. In this regard, an exemplary embodiment of the toggle 135is utilized in conjunction with a balloon 600 in a manner similar toand/or the same as that detailed above with respect to FIG. 22. Moreparticularly, FIGS. 25A, 25B and 25C schematically illustrate a sequenceaccording to an exemplary embodiment combining the above teachings. FIG.25A depicts the toggle 135 positioned at the puncture, with the wings136 and 137 drooping downward prior to applying tension to the filamentbeyond about that which is used to hold the toggle 135 against thepuncture (e.g., prior to cinching the loop 80, etc.) Balloon 600 isdepicted in a deflated or semi-deflated state, and is locatedlongitudinally proximally to the puncture (and toggle 135).

FIG. 25B depicts inflation of the balloon 600. As the balloon expandsoutward, wings 136 and 137 are forced outward towards the wall of theartery 1026. FIG. 25C depicts the balloon 600 inflated to at least aboutits maximum inflation dimensions. As can be seen, the wings 136 and 137are trapped against the wall of the artery between the wall and theballoon 600. At this time, additional tension is applied to the filament80 to move the plug 50 (not shown) towards the toggle 135, etc. Moreparticularly, FIG. 25C depicts how balloon 600 (single or doubleembodiment) may be used to orient the wings 136 and 137 of the toggle135 to assist with internal closure.

Exemplary embodiments of FIGS. 24A-D and/or 25A-C can be used tosubstantially and/or effectively statistically reduce the chances of thetoggle 135 dislodging and/or passing through the puncture and into thetract relative to the other embodiments detailed herein and/orvariations thereof. This statistical phenomenon may be, for example,because the additional area of the toggle 135 owing to the wings becausethe wings can be folded for insertion into the sheath 10. This ascompared to a toggle without folding wings, where the maximum size ofthe toggle is limited by the internal diameter of the sheath 10.

Exemplary embodiments of FIGS. 24A-D and/or 25A-C can be used inapplications where the puncture extends over a larger arcuate distanceas compared to toggles having smaller widths. For example, the puncturemay extend over an arc that extends about 20, 25, 30, 35, 40, 45, 50,55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160 170 and/orabout 180 degrees or more and/or angles in between these in one degreeincrements. The embodiments of FIGS. 24A-C and/or 25A-C cansubstantially and/or effectively statistically reduce the chances of thetoggle 135 dislodging and/or passing through such punctures puncture andinto the tract relative to the other embodiments detailed herein and/orvariations thereof.

FIGS. 26A and 26B depict another embodiment, where the filament isutilized to apply the above-mentioned force to the wings to expand thewings. In this regard, FIG. 26B is a cross-sectional view of section AAof the toggle 300 depicted in FIG. 26A. In this embodiment, the holes311 of the toggle 300 for the filament 80 are angled relative to thelateral axis 301 or positioned so as to aid in the support of thewidened portion, or ‘wings’. In an exemplary embodiment, this can aid inopening the toggle 300, which has hinge sections 300A and 300B extendingalong the midline. In an exemplary embodiment, loop 82 extends throughholes 311 as may be seen. The angle of the holes relative to axis 301has utility in that as the loop 82 is closed due to the tensioning offilament 80, the filament 80 applies a force onto wings 302A and 302B,lifting the wings upward and against the artery. It is noted that suchutility can also be achieved without the angling of the holes 311relative to axis 301. In this regard, because the holes 311 are outboardof the hinge sections 300A and 300B, the force resulting from thetensioning of the filament 80 is applied to the wings, thus forcing thewings upward and against the artery.

In addition to radiopaque marking schemes mentioned above, someembodiments detailed herein and/or variations thereof may includeadditional markers to ensure or otherwise substantially and/oreffectively statistically improve the chances of utilitarianly deployingthe toggles. Radiopaque markings on the tubes can aid in enabling theuser to estimate the amount of delivery tube and/or release tube thathas been pushed into the vessel. This can help the user avoidunutilitarian advancement of the toggle into the vessel (e.g., too muchadvancement), thereby obviating any adverse situations during deploymentsuch as catching of the toggle on the inner wall downstream. Thedelivery tube and/or the release tube may have radiopaque strips orrings at fixed distances. It may also have rings with increasingthicknesses. The gradient may be designed in proportion to a qualitativeassessment of distance advanced. The tube(s) may also have dots in placeof rings to differentiate between the radiopaque sheath tip and thedelivery tube.

In a similar vein, an exemplary embodiment includes a toggle or otherdegradable intraluminal sealing member that includes a radiopaquemarker. In an exemplary embodiment, one or more or all of theembodiments of toggles detailed herein and/or variations thereof mayinclude therein a relatively thin stainless steel radiopaque marker(thickness of 0.005″-0.010″). In some exemplary embodiments, the markermay have hollow features. FIGS. 27A-D depict such an exemplaryembodiment of a marker 2700, having hollow holes 2701 in arms 2702extending from a core 2703. Embedded in or otherwise attached to atoggle, the hollow features can be utilized to indicate toggleorientation during deployment. By way of example, depending on theorientation of the toggle relative to a viewing perspective, the holeswill appear anywhere from circular to highly elliptical. Moreparticularly, under fluoroscopic guidance, the holes appear circular at0 degrees. relative to the viewing perspective (FIG. 27A), elliptical at15 degrees. relative to the viewing perspective (FIG. 27B), moreelliptical at 30 degrees. relative to the viewing perspective (FIG. 27C)and highly-elliptical and/or closed off completely (i.e., one cannot seethrough the hole as the wall of the hole blocks the view) at 45 degrees.(FIG. 27D). Accordingly, there is a method of fluoroscopicallyconfirming the orientation of the toggle relative to a viewingperspective based on how the holes look relative to a viewingperspective prior to initiating any of the actions detailed hereinand/or variations thereof associated with deployment of the toggle.

More particularly, in an exemplary embodiment, during deployment of thetoggle, the holes may appear closed (or highly elliptical) as the toggleis released from the delivery instrument and hangs in the intraluminalspace. As the toggle is brought closer to the vessel wall as detailedherein, the varying degrees of circularity of the holes relative to aviewing perspective via fluoroscopy can provide the user with a visualconfirmation of accurate positioning and/or utilitarian positioning ofthe toggle.

In an exemplary embodiment, the marker can also be used as a reinforcingelement that reinforces the toggle and improves resistance to thetensioning of the filament as detailed above. This can have utilitarianvalue in that it can substantially and/or effectively statisticallyincrease the likelihood that the toggle stays in contact with the innerwall of the vessel throughout the period of resorption. This as comparedto that which would be the case in a similarly situated toggle withoutthe marker. In an exemplary embodiment, the “marker” need never be usedas a marker, but instead simply only as a reinforcing device.

As noted above, an exemplary embodiment includes a guide wire 20 thatpasses through holes in the plug 50. FIGS. 28, 29 and 30 depictexemplary embodiments, of such a configuration. In a further embodiment,there is an extra luminal sealing component 550, as depicted in FIG. 30,that is in the form of a stainless steel plate or bar about 0.5″ long orless and about 0.010″ thick or less placed between the hemostatic pad 50and the lock 60. The plate 550 can have utilitarian value in that it canincrease or otherwise result in utilitarian distribution of compressionforces on the plug 50 more evenly in order to achieve statisticallyand/or effective reliable hemostasis.

Embodiments disclosed herein and variations thereof include variousinterventional cardiology procedures which utilize large access sheathsto accommodate large devices. Non-exhaustive examples may includemethods that include steps of balloon aortic valvuloplasty (BAV) andpercutaneous aortic valve replacement (PAVR), both of which are utilizedwith sheaths ranging from 12-24F. Closure of access sites involvingsheaths this large are accomplished with the closure devices anddeployment instruments disclosed herein and variations thereof, as wellas methods for closing such access sites disclosed herein (whichincludes those disclosed in the above referenced applications, scaledfor such closure) instead of and/or in addition to surgical closureprocedures and/or the use of multiple traditional vascular closuredevices. In an exemplary embodiment, the devices and methods disclosedherein and variations thereof reduce by 50%, 75%, 90%, 95%, and/or 99%or more the failure rates associated with closure of access sites of thejust-mentioned procedures (i) such as those disclosed by, for example,Herrmann et al, discusses the successful use of multiple 8F Angio-Sealdevices (St Jude Medical, Minnetonka, Minn.) to close the arterialaccess site from BAV procedures, combating historical vascularcomplication rates from various studies ranging from 11-23%, (ii) and/orsuch as those disclosed by the Ramy et a12 report on the use threePerclose devices utilized for the closure of PAVR arterial access sites,suggesting deployment of the devices at 60 degree offsets to completelyclose the arteriotomy around the periphery.

It is noted that some embodiments include methods of utilizing thedevices and/or systems and/or components detailed herein and/orvariations thereof. Such methods can include individual method actionsassociated with/corresponding to the movement, positioning, use, etc.,of the devices and systems and components detailed herein and/orvariations thereof.

In an exemplary embodiment, there is a closure device for sealing apercutaneous puncture in a wall of a body passageway, the closure devicecomprising:

at least one of an:

anchor configured to engage an interior surface of the body passageway,and

a plug configured to engage an exterior surface of the body passageway;and

a guide wire configured to extend from an outside of the body to insidethe body passageway,

wherein the at least one of the anchor and the plug is associated withthe guide wire.

In an exemplary embodiment, there is a closure device as described aboveand/or below, wherein the anchor is associated with the guide wire suchthat the anchor is slidingly coupled to the guide wire. In an exemplaryembodiment, there is a closure device as described above and/or below,wherein the anchor includes a cavity, and the guide wire extends throughthe cavity. In an exemplary embodiment, there is a closure device asdescribed above and/or below, wherein the cavity is an orifice throughthe anchor. In an exemplary embodiment, there is a closure device asdescribed above and/or below, wherein the cavity is a notch on aperiphery of the anchor.

In an exemplary embodiment, there is a closure device as described aboveand/or below, wherein the plug is associated with the guide wire suchthat the plug is slidingly coupled to the guide wire.

In an exemplary embodiment, there is a deployment instrument fordeploying a closure device for sealing a percutaneous puncture in a wallof a body passageway, the deployment instrument comprising:

the closure device;

a carrier device, wherein the carrier device is configured to hold theclosure device in a pre-deployment state; and

a guide wire, the guide wire passing through at least a portion of theclosure device.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the closure device includes atoggle, wherein the guide wire passes through the toggle. In anexemplary embodiment, there is a deployment instrument as describedabove and/or below, wherein the closure device includes a plug, whereinthe guide wire passes through the plug. In an exemplary embodiment,there is a deployment instrument as described above and/or below,further comprising:

a tamper, wherein the guide wire is associated with the tamper.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the tamper includes a plurality oflumens, wherein the guide wire extends through one of the lumens. In anexemplary embodiment, there is a deployment instrument for deploying aclosure device for sealing a percutaneous puncture in a wall of anartery, the deployment instrument comprising:

the closure device, wherein the closure device includes a toggle and aplug connected to the toggle; and

an actuatable assembly having an actuatable portion configured to extendinto the artery such that the toggle is located in the artery while, ina first state, effectively maintaining a relative position of the togglewith respect to the actuatable portion.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the actuatable assembly isconfigured to, upon actuation from the first state to a second state,permit the toggle to move relatively freely relative to the actuatableportion while connected to the plug and while the toggle is in theartery.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the actuatable assembly isconfigured to extend into the artery such that at least a portion of theplug is located in the artery; and

actuatable assembly is configured to, upon actuation from the firststate to a second state, permit the toggle to move relatively freelyrelative to the plug while connected to the plug and while the toggleand at least a portion of the plug is in the artery.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the actuatable assembly includes afirst lumened component in which the plug is located and a secondlumened component in which the first lumened component is located; and

wherein the instrument is configured to, upon actuation of theactuatable assembly, move the second lumened component relative to thefirst lumened component and/or visa-versa, thereby actuating from thefirst state to the second state and thereby permitting the toggle tomove relatively freely relative to the actuatable portion whileconnected to the plug.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein at least a portion of the toggleis located within the lumen of the second lumened component; and

wherein movement of the second lumened component relative to the firstlumened component and/or visa-versa, upon actuation from the first stateto the second state, results in the toggle being fully exposed outsidethe second lumen component.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, further comprising:

a knob configured to turn relative to at least one of the first lumenedcomponent or the second lumened component to actuate the actuatableassembly.

In an exemplary embodiment, there is a deployment instrument fordeploying a closure device for sealing a percutaneous puncture in a wallof a body passageway, the closure device including an anchor, a plug anda contiguous elongate filament configured to draw the plug towards theanchor upon the application of tension to the filament in a directionaway from the anchor, the deployment instrument comprising:

a carrier assembly, wherein the carrier assembly is configured to holdthe closure device in a pre-deployment state; and

a tensioner assembly located inside the carrier assembly.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the carrier assembly includes afirst lumened component, wherein the first lumened component isconfigured to hold the closure device in a lumen thereof; and

wherein the tensioner assembly is located in the lumen.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the tensioner assembly includes acartridge comprising a handle, a spring, and a suture interface thatmoves relative to the handle, movement relative to the handle causing atleast one of compression or extension of the spring; and

wherein the handle, the spring and the suture interface are locatedwithin the lumen.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the tensioner assembly isconfigured to increase the tension in the filament upon linear movementof the tensioner assembly away from the wall of the body passageway whenthe closure device is anchored to the wall via the anchor such that thetension is gradually increased as the tensioner assembly is movedbetween a first linear distance and a second linear distance greaterthan the first linear distance from the wall of the body passageway.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the deployment instrument isconfigured such that movement of the carrier assembly away from the wallof the body passageway when the closure device is anchored to the wallvia the anchor with the cartridge in the carrier assembly while thefilament is under tension withdraws the cartridge from the carrierassembly; and

wherein the deployment instrument is configured such that the movementwithdrawing the carrier assembly results in movement of the tensionerassembly from a first location that is a linear distance from the wallof the body passageway less than the first linear distance to a secondlocation that is greater than the linear distance from the wall to thefirst location and less than or about equal to the first linear distancefrom the wall of the body passageway.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the deployment instrument isconfigured such that movement of the carrier assembly away from the wallof the body passageway when the closure device is anchored to the wallvia the anchor between a first linear distance from the wall to a secondlinear distance from the wall greater than the first linear distancewhile the filament is under tension results in withdrawal of thecartridge out of the first lumen; and

wherein the tensioner assembly is configured to increase the tension inthe filament upon linear movement of the handle away from the wall ofthe body passageway when the closure device is anchored to the wall viathe anchor such that the tension is gradually increased as the tensionerassembly is moved between a third linear distance and a fourth lineardistance greater than the third linear distance from the wall of thebody passageway, wherein the third linear distance is greater than orabout equal to the second linear distance.

A closure device for sealing a percutaneous puncture in a wall of a bodypassageway, the closure device comprising:

a toggle configured to engage an interior surface of the bodypassageway; and

a filament threaded through three or more orifices in the toggle.

In an exemplary embodiment, there is a closure device as described aboveand/or below, wherein the filament is threaded through four orifices inthe toggle. In an exemplary embodiment, there is a deployment instrumentas described above and/or below, wherein in the following order:

the filament enters a first orifice at a first side of the toggle andexits the first orifice at a second side opposite the first side of thetoggle;

the filament enters a second orifice at a second side of the toggle andexits the second orifice at the first side of the toggle;

the filament enters a third orifice at the first side of the toggle andexits the third orifice at the second side opposite the first side ofthe toggle; and

the filament enters a fourth orifice at the second side of the toggleand exits the fourth orifice at the first side of the toggle.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, wherein the four orifices are generallylinearly arranged across the toggle in an order of the first orifice,the second orifice, the third orifice and the fourth orifice. In anexemplary embodiment, there is a closure device for sealing apercutaneous puncture in a wall of a body passageway, the closure devicecomprising:

a toggle configured to engage an interior surface of the bodypassageway;

a looped filament extending through the toggle; and

a washer spanning across the loop and associated with the filament attwo locations such that the filament of the look cannot constrict onitself proximate the washer.

In an exemplary embodiment, there is a closure device as described aboveand/or below, further comprising:

a first plug, wherein the filament is threaded through the first plugbetween the washer and the toggle on a first side of the loop; and

a second plug, wherein the filament is threaded through the second plugbetween the washer and the toggle on a second side of the loop oppositethe first side.

In an exemplary embodiment, there is a closure device for sealing apercutaneous puncture in a wall of a body passageway, the closure devicecomprising:

a toggle configured to engage an interior surface of the bodypassageway;

a looped filament extending through the toggle;

a first plug, wherein the filament is threaded through the first plug ona first side of the loop; and

a second plug, wherein the filament is threaded through the second plugon a second side of the loop opposite the first side.

In an exemplary embodiment, there is a deployment instrument fordeploying a closure device for sealing a percutaneous puncture in a wallof a body passageway, the closure device including an anchor, a plug anda contiguous elongate filament configured to draw the plug towards theanchor upon the application of tension to the filament in a directionaway from the anchor, the deployment instrument comprising:

a closure device including an anchor and a pad connected to the anchorvia a looped filament;

a first tamper lumen, the filament extending through the first tamperlumen on a first side of the loop; and

a second tamper lumen, the filament extending through the second tamperlumen on a second side of the loop.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, further comprising:

a first tamper, the first tamper including the first tamper lumen; and

a second tamper, the second tamper including the second tamper lumen.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below, further comprising:

a tamper, wherein the first and second tamper lumens extend through thetamper.

In an exemplary embodiment, there is a deployment instrument fordeploying a closure device for sealing a percutaneous puncture in a wallof a body passageway, the closure device including an anchor, a plug anda contiguous elongate filament configured to draw the plug towards theanchor upon the application of tension to the filament in a directionaway from the anchor, the deployment instrument comprising:

a closure device, the closure device including a toggle and a plugconnected to the toggle via a looped filament; and

a tensioner assembly, the tensioner assembly spanning the loop and beingspring biased to resist closure of the loop.

In an exemplary embodiment, there is a deployment instrument asdescribed above and/or below wherein the tensioner assembly includes afirst and second arm, the arms being spring biased away from oneanother, the arms being respectively connected to sides of the loop,such that closure of the loop imparts a force onto the arms that drivesthe arms towards one another. In an exemplary embodiment, there is amethod of closing a puncture in an artery wall, comprising:

inserting an anchor through the puncture into the artery;

moving an expandable device along the longitudinal direction of theartery to a location longitudinally proximate the puncture andlongitudinally proximate the anchor; and

expanding the expandable device, thereby applying a compressive force tothe anchor.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein the compressive force compresses the anchor against theartery wall. In an exemplary embodiment, there is a method as describedabove and/or below, wherein the expandable device is an occlusionballoon. In an exemplary embodiment, there is a method as describedabove and/or below, further comprising:

moving a second occlusion balloon along the longitudinal direction ofthe artery; and

occluding the artery.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

while the expandable device is applying the compressive force, moving aplug against the artery wall proximate the anchor.

In an exemplary embodiment, there is a closure device for sealing apercutaneous puncture in a wall of a body passageway, the closure devicecomprising:

an anchor configured to engage an interior surface of the bodypassageway, wherein the anchor includes a first portion and a secondportion, the first portion extending away from the second portion, andwherein at least one of the first portion and the second portion ishinged.

In an exemplary embodiment, there is a closure device as described aboveand/or below,

wherein the anchor includes a main body between the first portion andthe second portion, wherein the hinge is between the first portion andthe main body.

In an exemplary embodiment, there is a closure device as described aboveand/or below,

wherein the anchor includes a main body between the first portion andthe second portion; the first portion and the second portion are hinged;the hinge of the first portion is between the first portion and the mainbody; and

wherein the hinge of the second portion is between the second portionand the main body.

In an exemplary embodiment, there is a closure device as described aboveand/or below,

wherein the hinge comprises a notch in the anchor.

In an exemplary embodiment, there is a closure device as described aboveand/or below,

wherein the anchor includes a plurality of orifices through which afilament is looped, one side of the loop extending through one orificeand the other side of the loop extending through the other orifice; and

wherein the hinge is between the orifices.

In an exemplary embodiment, there is a closure device for sealing apercutaneous puncture in a wall of a body passageway, the closure devicecomprising:

an anchor configured to engage an interior surface of the bodypassageway, wherein the anchor includes a fluoroscopic marker, themarker including a hole having a circular cross-sectional area extendingtherethrough.

In an exemplary embodiment, there is a closure device as described aboveand/or below,

wherein the marker includes a plurality of holes having respectivecircular cross-sectional areas extending therethrough.

In an exemplary embodiment, there is a closure device as described aboveand/or below, wherein the marker includes arms extending from oneanother, the respective arms having respective holes. In an exemplaryembodiment, there is a method of sealing a percutaneous puncture in abody passageway of a living being, the method comprising:

inserting an anchor into the body passageway;

inserting at least a portion of a plug coupled to the anchor into thebody passageway; and

closing the puncture by moving the plug towards the anchor.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

inserting in its entirety the plug into the body passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the anchor is held effectively rigidly relative to the plug whileinserting at least a portion of the plug into the body passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

at least a portion of the anchor is enclosed within a delivery apparatuswhile inserting at least a portion of the plug into the body passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the delivery apparatus is a delivery tube.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

releasing the anchor after it is held effectively rigidly relative tothe plug such that the anchor is effectively movably connected to theplug while at least a portion of the plug is in the body passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the action of inserting the anchor into the body passageway is executedwhile the anchor is associated with a guidewire extending into the bodypassageway through the puncture from outside the body passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

passing the anchor completely through an insertion sheath while at leasta portion of the anchor is enclosed within the delivery apparatus.

In an exemplary embodiment, there is a method of sealing a percutaneouspuncture in a body passageway of a living being, the method comprising:

inserting a guidewire into the body passageway such that the guidewireextends from outside the body passageway, through the puncture and intothe body passageway; and

inserting an anchor into the body passageway while the anchor isassociated with the guidewire extending from outside the bodypassageway, through the puncture and into the body passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the guidewire extends through the anchor, and the anchor slides alongthe guidewire while inserting the anchor into the body passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the guidewire extends through a plug that is coupled to the anchor, andthe plug slides along the guidewire while inserting the anchor into thebody passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

associating the guidewire with the anchor prior to inserting the anchorinto the body passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the action of associating the guidewire is executed while the punctureis open.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the action of associating the guidewire is executed in relatively closetemporal proximity to at least one of forming the puncture and closingthe puncture.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

obtaining access to a deployment instrument including a closure deviceincluding the anchor and the guidewire while the anchor is associatedwith the guidewire.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the action of obtaining access includes opening a package containing thedeployment instrument including the closure device including the anchorand the guidewire while the anchor is associated with the guidewire.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the package is at least one of a hermetically sealed.

In an exemplary embodiment, there is method of sealing a percutaneouspuncture in a body passageway of a living being, the method comprising:

inserting a distal end section of a deployment instrument into thepuncture from outside of the passageway, wherein the distal end sectionof the deployment instrument rigidly supports an anchor, the distal endsection including a first component and a second component being inactuatable relationship to one another.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

actuating the deployment instrument to move the first component relativeto the second component and/or visa-versa, wherein the actuationrelieves the rigid support of the anchor, thereby enabling the anchor toeffectively move relative to the distal end section.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

inserting the distal end section into an insertion sheath extendingthrough the puncture from outside of the passageway to inside of thepassageway while the distal end section of the deployment instrumentrigidly supports the anchor.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

inserting the insertion sheath into the puncture.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein:

the insertion sheath is inserted into the puncture such that theinsertion sheath substantially deforms from a linear configuration.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

after inserting the insertion sheath into the puncture such that theinsertion sheath substantially deforms from the linear configuration,moving the insertion sheath relative to the deployment instrument and/orvisa-versa so that the anchor is exposed from the insertion sheath andin the passageway.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

actuating the deployment instrument to move the first component relativeto the second component and/or visa-versa, wherein the actuationrelieves the rigid support of the anchor, thereby enabling the anchor toeffectively move relative to the distal end section.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

after actuating the deployment instrument, moving the deploymentinstrument in a distal direction so that the anchor abuts a wall of thepassageway proximate the puncture.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising:

after actuating the deployment instrument, moving the deploymentinstrument in a distal direction so that the anchor abuts a wall of thepassageway proximate the puncture and so that a plug contained in thedeployment instrument moves towards the anchor and towards the puncture.

In an exemplary embodiment, there is method of sealing a percutaneouspuncture in a wall of a body passageway, comprising:

providing a deployment instrument carrying a tensioner assembly and aclosure device within the deployment instrument, the closure deviceincluding an anchor, a plug and a contiguous elongate filamentconfigured to draw the plug towards the anchor upon the application oftension to the filament in a direction away from the anchor;

positioning a distal end of the deployment instrument through thepuncture into the body passageway such that the anchor is positioned inthe body passageway;

pulling the deployment instrument away from the puncture while thefilament is connected to the tensioner assembly such that a mechanicallyinduced tension force is applied to the filament causing the tensionerassembly to be withdrawn from an interior of the deployment instrument;and

pulling the tensioner assembly away from the puncture while the filamentis connected to the tensioner assembly such that the mechanicallyinduced tension force is applied to the filament such that the tensionforce increases with increasing distance of the tensioner assembly awayfrom the puncture to draw the anchor and the seal towards each other andinto engagement with the wall of the body passageway at respectivelyopposite sides of the wall.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein pulling the tensioner assembly away from the puncturewhile the filament is connected to the tensioner assembly results in theapplication of a linearly increasing mechanically induced tension forceto the filament. In an exemplary embodiment, there is a method asdescribed above and/or below, wherein the mechanically inducedincreasing tension force is produced via compression of a spring. In anexemplary embodiment, there is a method as described above and/or below,wherein the tensioner assembly includes a handle that is movablerelative to a first location on the tensioner assembly to which thefilament is connected, the method further comprising continuing to pullthe tensioner assembly away from the puncture by pulling on the handleuntil the handle no longer moves relative to the first location on thetensioner assembly.

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not limitation. It will be apparent to persons skilledin the relevant art that various changes in form and detail can be madetherein without departing from the spirit and scope of the invention.Thus, the breadth and scope of the present invention should not belimited by any of the above-described exemplary embodiments, but shouldbe defined only in accordance with any future claims and theirequivalents.

What is claimed:
 1. A deployment instrument configured to seal apercutaneous puncture in a wall of an artery, the deployment instrumentconfigured to slide along a guide wire positionable through thepuncture, the deployment instrument comprising: a closure deviceincluding a toggle and a plug connected to the toggle, the toggledefining a distal surface, an opposed proximal surface, and a cavitythat extends from the distal surface to the proximal surface, the cavitysized and configured to receive the guide wire so that at least thetoggle is slidable along the guide wire when the guide wire is 1)received by the cavity, and 2) is positioned to extend through thepercutaneous puncture; a handle member; a delivery component that issupported by the handle member and that extends relative to the handlemember in a distal direction; a release component supported by thehandle member and extending relative to the handle member along thedelivery component in the distal direction; and an actuator supported bythe handle member and operably coupled to the delivery component and therelease component, the actuator configured to actuate at least one ofthe delivery component and the release component from a first statewhere the toggle is fixed between the distal end of the deliverycomponent and the release component, into a second state where thetoggle is released from between the distal end of the delivery componentand the release component.
 2. The instrument of claim 1, wherein therelease component includes a release component body, the releasecomponent body defining a rear end and a front end spaced from the rearend in the distal direction, the front end defining an inner surface,wherein in the first state a portion of the toggle is in contact with A)the inner surface of the release component, and B) the distal end of thedelivery component.
 3. The instrument of claim 2, wherein the actuatoris supported by the handle member so that an entirety of the actuator isspaced apart from the front end of the release component in a proximaldirection that is opposite to the distal direction.
 4. The instrument ofclaim 3, wherein actuation of the actuator causes translation of therelease component so as to transition the release component from thefirst state to the second state.
 5. The instrument of claim 1, whereinactuation of the actuator causes the release component to move relativeto the delivery component in a proximal direction that is opposite tothe distal direction so as to release the toggle.
 6. The instrument ofclaim 1, wherein the release component is elongated in the distaldirection, and the release component defines a lumen that extendstherethrough along the distal direction.
 7. The instrument of claim 6,wherein the delivery component is disposed at least partially in thelumen of the release component.
 8. The instrument of claim 1, whereinthe actuator is a lever, wherein actuation of the lever causes therelease of the toggle from the release component.
 9. The instrument ofclaim 1, wherein the actuator is a knob, wherein actuation of the knobcauses the release of the toggle from the release component.
 10. Theinstrument of claim 1, wherein the closure device includes a filamentthat connects the toggle to the plug.
 11. The instrument of claim 10,further comprising a locking member disposed along the filament in aproximal direction that is opposite the distal direction, and a tamperconfigured to slide along the filament in the distal direction so as tourge the locking member toward the plug.
 12. The instrument of claim 11,wherein the tamper includes a first lumen through which the filamentextends, a second lumen sized to receive the guidewire therethrough. 13.The instrument of claim 1, wherein the cavity is an orifice that extendsthrough the toggle.
 14. The instrument of claim 1, wherein the cavity isa notch on a periphery of the toggle.
 15. The instrument of claim 1,wherein the plug has an aperture configured to receive the guide wire,such that the toggle and the plug are slidable along the guide wire whentoggle and the plug receive the guidewire.
 16. The instrument of claim1, wherein the toggle includes opposed ends, wherein the distal end ofthe delivery component defines an angled portion that receives one endof the opposed ends of the toggle when at least one of the deliverycomponent and the release component is in the first state.
 17. Adeployment instrument configured to seal a percutaneous puncture in awall of an artery, the deployment instrument comprising: a closuredevice including a toggle and a plug connected to the toggle; a handlemember; a delivery component that is supported by the handle member andthat extends relative to the handle member in a distal direction, thedelivery component having a proximal end and a distal end spaced fromthe proximal end in the distal direction, the proximal end beingsupported by the handle member such that the distal end of the deliverycomponent is spaced from the handle member in the distal direction; arelease component supported by the handle member, the release componenthaving a rear end and a front end spaced from the rear end in the distaldirection, the rear end being supported by the handle member such thatthe front end is spaced from the handle member in the distal direction;and an actuator supported by the handle member and operably coupled tothe release component, such that, an entirety of the actuator is spacedapart from the front end of the release component in a proximaldirection that is opposite to the distal direction, wherein the actuatoris configured to cause the release component to transition from a firststate where the toggle is fixed relative to the release component and tothe delivery component so that the toggle is stationary for insertioninto the artery, and a second state where the toggle is released fromthe release component and the delivery component so that the toggle ismoveable relative to the distal end of the delivery component.
 18. Theinstrument of claim 17, wherein the actuator is a rotatable actuator,and rotation of the actuator causes translation of the release componentso as to transition the release component from the first state to thesecond state.
 19. The instrument of claim 18, further comprising aninserter sheath defining a proximal end, a distal end spaced from theproximal end of the inserter sheath in the distal direction, and a lumenthat extends from the proximal end of the inserter sheath to the distalend of the inserter sheath along the distal direction.
 20. Theinstrument of claim 19, wherein the release component and the deliverycomponent are configured to carry the toggle to a location that isspaced out of the distal end of the of the inserter sheath in the distaldirection when the release component is in the first state.
 21. Theinstrument of claim 18, wherein the rotatable actuator is a lever,wherein rotation of the lever cause the release of the toggle from therelease component.
 22. The instrument of claim 18, wherein the rotatableactuator is a knob, wherein rotation of the knob cause the release ofthe toggle from the release component.
 23. The instrument of claim 17,wherein actuation of the actuator causes the release component to moverelative to the delivery component in a proximal direction that isopposite to the distal direction so as to release the toggle.
 24. Theinstrument of claim 17, wherein the release component is elongated alongthe distal direction, wherein the release component defines a lumen thatextends from the rear end to the front end along the distal direction.25. The instrument of claim 24, wherein the delivery component isdisposed at least partially in the lumen of the release component. 26.The instrument of claim 17, wherein the closure device includes afilament that connects the toggle to the plug.
 27. The instrument ofclaim 26, further comprising a locking member disposed along thefilament in the proximal direction, and a tamper configured to slidealong the filament so as to urge the locking member toward the plug. 28.The instrument of claim 17, wherein the toggle defines a distal surfaceand an opposed proximal surface, and a cavity that extends from thedistal surface to the proximal surface, the cavity sized and configuredto receive a guide wire.
 29. The instrument of claim 17, wherein thetoggle includes opposed ends, and the distal end of the deliverycomponent defines an angled portion that receives one end of the opposedends of the toggle when the release component is in the first state. 30.The instrument of claim 17, wherein in the first state the toggle isfixed A) between the delivery component and the release component, andB) relative to the distal end of delivery component, and in the secondstate the toggle is released from between the release component and thedelivery component.